53 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 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 Tablet/Capsule Specifications
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 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%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.