1,523 recalls · Class III, newest first
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Reason Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason Failed Moisture Limits
Reason Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making…
Reason Labelling: Missing label.
Reason Subpotency: Out-of-specification stability test result for low potency was obtained.
Reason Labeling: Label mix-up
Reason Cross Contamination with Other Products: trace amounts of octreotide found during testing
Reason Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Reason Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Reason Superpotent and Subpotent; low and high assay results
Reason Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Reason Subpotent
Reason Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for…
Reason Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.