Prescription and over-the-counter medications
The Harvard Drug Group LLC
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Glenmark Pharmaceuticals Inc., USA
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
A-S Medication Solutions
Presence of Foreign Tablets/Capsules.
Lack of Assurance of Sterility
Consumer Product Partners
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Presence of foreign substance: Presence of Benzene.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Lack of Assurance of Sterility
Presence of foreign substance: Presence of Benzene.
Fruit Of The Earth
Chemical contamination: presence of benzene
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
MYLAN PHARMACEUTICALS
Failed Dissolution Specifications - low dissolution results