Over-the-Counter

CGMP Deviations

CGMP Deviations

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

CGMP Deviations

CGMP Deviations

CGMP Deviations: Released product should have been rejected.

cGMP Deviations

cGMP Deviations

cGMP Deviations

cGMP Deviations

cGMP Deviations

cGMP Deviations

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.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: products were stored outside the drug label specifications.

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.

CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

Microbial Contamination of Non-Sterile Products

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Subpotent Drug

Subpotent Drug

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

cGMP Deviations

cGMP Deviations

cGMP Deviations.

cGMP Deviations.

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Microbial Contamination of Non-Sterile Products

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.