Recalls in Maine (page 31)
3867 recalls.
- Dexamethasone Sodium Phosphate Injection recall (SOMERSET THERAPEUTICS LLC)
DrugClass IIReported March 25, 2026 · Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs... - Children's Ibuprofen Oral Suspension recall (STRIDES PHARMA INC)
DrugClass IIReported March 25, 2026 · Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. - Battery Charging Station recall (Datascope Corp.)
Medical deviceClass IIIReported March 25, 2026 · The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to ... - Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number:... recall (Hologic, Inc.)
Medical deviceClass IIReported March 25, 2026 · Due to product exhibiting potential to generate either invalid or false negative results. - Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number:... recall (Diagnostica Stago, Inc.)
Medical deviceClass IIReported March 25, 2026 · After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. - Convatec recall (ConvaTec, Inc)
Medical deviceClass IIReported March 25, 2026 · Drainable large pouch may leak due to manufacturing issue. - Convatec recall (ConvaTec, Inc)
Medical deviceClass IIReported March 25, 2026 · Drainable large pouch may leak due to manufacturing issue. - Convatec recall (ConvaTec, Inc)
Medical deviceClass IIReported March 25, 2026 · Drainable large pouch may leak due to manufacturing issue. - Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion ... recall (Elekta, Inc.)
Medical deviceClass IIReported March 25, 2026 · Due to adapter not being properly aligned or locked in place. - Cub Pediatric Crib recall (Stryker Medical Division of Stryker Corporation)
Medical deviceClass IIReported March 25, 2026 · Cribs sold in the USA are missing two access door warning labels. - Artegraft Vascular Graft recall (LeMaitre Vascular, Inc.)
Medical deviceClass IIReported March 25, 2026 · Labeling mix-up resulting in the incorrect lot outer packaging of product. - Brand Name: Welch Allyn recall (Baxter Healthcare Corporation)
Medical deviceClass IIReported March 25, 2026 · Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible... - MICS3 Angled Sagittal Saw Attachment recall (Howmedica Osteonics Corp.)
Medical deviceClass IIReported March 25, 2026 · A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the... - Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1 recall (GE Medical Systems, LLC)
Medical deviceClass IIReported March 25, 2026 · There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local... - Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1 recall (GE Medical Systems, LLC)
Medical deviceClass IIReported March 25, 2026 · There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local... - Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1 recall (GE Medical Systems, LLC)
Medical deviceClass IIReported March 25, 2026 · There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local... - Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software... recall (Abbott Diagnostics Scarborough, Inc.)
Medical deviceClass IIReported March 25, 2026 · It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. - Aisstxoer Adult Bicycle Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Amazon by YXTDZ Store
Consumer productReported March 19, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional... - Amazon Recalls Amazon Basics Camping Folding Pocket Knives Due to Laceration Hazard
Consumer productReported March 19, 2026 · The folding mechanism on the blade can fail to remain properly secured in the closed position, posing a laceration hazard. - Electrolux Group Recalls Frigidaire Gas Ranges Due to Burn Hazard
Consumer productReported March 19, 2026 · The ovens in the ranges can experience a delayed ignition of the oven's bake burner, posing a risk of burn hazards to users. - Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Infant Walkers; Sold on Amazon by Goregent Official Store
Consumer productReported March 19, 2026 · The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a... - Lifetime Brands Recalls BUILT LUUM Light Up Tumblers Due to Risk of Choking and Battery Ingestion Hazards
Consumer productReported March 19, 2026 · The recalled LED tumblers can break, making the button cell batteries accessible to children and posing choking and ingestion hazards. When button cell or coin... - Specialized Bicycle Components Recalls Specialized Turbo Como SL Electric Bicycles Due to Risk of Serious Injury or Death from Fall Hazard
Consumer productReported March 19, 2026 · The bike's fork steerer tube can develop a small fatigue crack that can lead to a progressive failure of the fork, posing a fall hazard. - Tainoki Fine Furniture Recalls Office Chairs Due to Risk of Serious Injury and Fall Hazard
Consumer productReported March 19, 2026 · The recalled chairs' base can bend, posing a fall hazard. - Wagner Spray Tech Recalls 900 Series Power Steamers Due to Burn Hazard
Consumer productReported March 19, 2026 · The attached hose can get excessively hot and the nozzle/gun can expel hot water during use and after the trigger is engaged, posing a serious burn hazard to... - CHEMISTRY ANALYZER AU5800 recall (Beckman Coulter Mishima K.K.)
Medical deviceClass IIReported March 18, 2026 · A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15... - DxC 700 AU recall (Beckman Coulter Mishima K.K.)
Medical deviceClass IIReported March 18, 2026 · A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15... - PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers:... recall (Physio-Control, Inc.)
Medical deviceClass IIReported March 18, 2026 · Due to pediatric defibrillator electrode delamination - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog... recall (Exactech, Inc.)
Medical deviceClass IIReported March 18, 2026 · Impactor handle may be missing cross-pin - Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog... recall (Exactech, Inc.)
Medical deviceClass IIReported March 18, 2026 · Impactor handle may be missing cross-pin - Rosabella brand MORINGA recall (Ambrosia Brands LLC)
FoodClass IReported March 18, 2026 · Product may be contaminated with Salmonella - Icosapent Ethyl Capsules recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIReported March 18, 2026 · Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. - Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE recall (Medline Industries, LP)
Medical deviceClass IIReported March 18, 2026 · Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may... - Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN recall (Medline Industries, LP)
Medical deviceClass IIReported March 18, 2026 · Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may... - Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART recall (Medline Industries, LP)
Medical deviceClass IIReported March 18, 2026 · The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target... - Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal... recall (Altruan GmbH)
Medical deviceClass IIReported March 18, 2026 · Product not cleared by the FDA. - Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci recall (Altruan GmbH)
Medical deviceClass IIReported March 18, 2026 · Product not cleared by the FDA. - Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic... recall (Altruan GmbH)
Medical deviceClass IIReported March 18, 2026 · Product not cleared by the FDA. - CLARITY II Laser System recall (Lutronic Corporation)
Medical deviceClass IIReported March 18, 2026 · Reports of devices sparking/popping and potentially burning patients. - HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product... recall (Covidien LLC)
Medical deviceClass IIReported March 18, 2026 · Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote... - Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor recall (International Life Sciences)
Medical deviceClass IIReported March 18, 2026 · Augmentation devices failed bacterial endotoxin testing. - Artelon FlexBand Plus Ref: 41054 & 41057 recall (International Life Sciences)
Medical deviceClass IIReported March 18, 2026 · Augmentation devices failed bacterial endotoxin testing. - Artelon FlexBand Dynamic Matrix Ref: 31057 recall (International Life Sciences)
Medical deviceClass IIReported March 18, 2026 · Augmentation devices failed bacterial endotoxin testing. - EndoVive Safety PEG Kit recall (Boston Scientific Corporation)
Medical deviceClass IIReported March 18, 2026 · Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of... - Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm recall (Medartis AG)
Medical deviceClass IIReported March 18, 2026 · Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. - Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm recall (Medartis AG)
Medical deviceClass IIReported March 18, 2026 · Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. - Owner's Booklets and Instructions for Use that are used with the following blood... recall (Trividia Health, Inc.)
Medical deviceClass IReported March 18, 2026 · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code... - Owner's Booklets and Instructions for Use that are used with the following blood... recall (Trividia Health, Inc.)
Medical deviceClass IReported March 18, 2026 · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code... - Owner's Booklets and Instructions for Use that are used with the following blood... recall (Trividia Health, Inc.)
Medical deviceClass IReported March 18, 2026 · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code... - Owner's Booklets and Instructions for Use that are used with the following blood... recall (Trividia Health, Inc.)
Medical deviceClass IReported March 18, 2026 · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model SL Connection Component incl. PE-Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model SL Connection Component incl. PE-Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model Replacement Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Endo-Model SL Connection Component incl. PE-Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported March 18, 2026 · The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - Raz-AT recall (Raz Design Inc)
Medical deviceClass IIReported March 18, 2026 · Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place. - IBA Proton Therapy System - PROTEUS 235 recall (Ion Beam Applications S.A.)
Medical deviceClass IIReported March 18, 2026 · It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS... - 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk... recall (Becton Dickinson & Company)
Medical deviceClass IIReported March 18, 2026 · During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. - LFTE USA Recalls Playground Swing Set Seats Due to Fall Hazard
Consumer productReported March 13, 2026 · The rivets used to support the swing seat can fail, posing a fall hazard to children. - 17 Stories Furniture 14-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units; Imported by Hong Kong Baojia International
Consumer productReported March 12, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - LIVEHOM 11-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by Simplehome
Consumer productReported March 12, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - ProRider Recalls Bicycle Helmets Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets
Consumer productReported March 12, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional... - Stoney Games Recalls Kluster Magnet Chess Games Due to Risk of Serious Injury or Death from Magnet Ingestion; Violates Mandatory Standard for Toys
Consumer productReported March 12, 2026 · The recalled magnet games violate the mandatory standard for toys because they contain loose high-powered magnets that fit within CPSC's small parts cylinder... - Gelsoft Plus recall (Vascutek, Ltd.)
Medical deviceClass IIReported March 11, 2026 · Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry... - Amnesteem recall (MYLAN PHARMACEUTICALS INC)
DrugClass IIReported March 11, 2026 · Failed Dissolution Specifications - Sodium Iodide recall (Radnostix)
DrugClass IIReported March 11, 2026 · Presence of Particulate Matter: Due to production issues - MAXIMUM recall (HTO Nevada Inc. dba Kirkman)
DrugClass IIReported March 11, 2026 · Stability Data Does Not Support Expiry Date. - MAXIMUM recall (HTO Nevada Inc. dba Kirkman)
DrugClass IIReported March 11, 2026 · Stability Data Does Not Support Expiry Date. - FIVE-STAR recall (HTO Nevada Inc. dba Kirkman)
DrugClass IIReported March 11, 2026 · Stability Data Does Not Support Expiry Date. - Product label: Temozolomide Capsules recall (Rising Pharma Holding, Inc.)
DrugClass IIReported March 11, 2026 · Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing - Midodrine Hydrochloride Tablets recall (The Harvard Drug Group LLC)
DrugClass IIReported March 11, 2026 · Defective container; inadequately sealed blister packaging. - Nilotinib Capsules recall (Cipla USA, Inc.)
DrugClass IIIReported March 11, 2026 · Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection...