Drugs Recalls

CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Subpotent: Out of Specification for Assay Test at the 3-month time point.

CGMP Deviations

CGMP Deviations

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Failed Impurities/Degradation Specifications

Out of Specification result observed in content uniformity testing

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Lack of assurance of sterility: Lack of validation data for sanitization cycles