1,709 recalls · Class III, newest first
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Reason Failed Tablet/Capsule Specifications
Reason Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability…
Reason Defective Container: Firm received complaints of broken tube at the seal.
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Reason Discoloration
Reason LABELING: LABEL MIX-UP.
Reason Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone…
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Reason Label mix-up: Carton incorrectly labeled.
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
Reason Cross contamination with other products
Reason Cross contamination with other products
Reason Cross contamination with other products.
Reason Cross contamination with other products.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.