Over-the-Counter

cGMP Deviations

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Lack of Assurance of Sterility

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

CGMP Deviations

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

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.

cGMP deviations

CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

CGMP Deviations: product held outside appropriate storage temperature conditions.