76 recalls · Class III, newest first
Reason Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Reason LABELING: LABEL MIX-UP
Reason LABELING: LABEL MIX-UP
Reason Failed Impurities/Degradation Specifications
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 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.