Drugs Recalls

Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Subpotent Drug

Lack of Assurance of Sterility

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

Defective Container

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Defective Container

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Lack of Assurance of Sterility

Defective Container

Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

Failed Impurities/Degradation Specifications.