AbbVie Refresh LACRI-LUBE recall — FDA D-0665-2024
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
LABELING: LABEL MIX-UP.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed Dissolution Specifications: below specification results
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
CGMP Deviations: sterile water not used for production
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
CGMP Deviations: sterile water not used for production
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained…
Defective container; yellow colored spike from cap lodged in the nozzle
Label mix-up: Carton incorrectly labeled.
Defective container: potential for non-sealed pouches which can lead to product leakage.
Lack of Assurance of Sterility
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Failed Dissolution Specifications
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