Prescription and over-the-counter medications
Dr. Reddy's Laboratories
Subpotent Drug: Subpotent atorvastatin.
Liberty Drug & Surgical
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Liberty Drug & Surgical
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Liberty Drug & Surgical
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Liberty Drug & Surgical
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Presence of Particulate Matter
Presence of Particulate Matter
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Failed Dissolution Testing: Failed 24 month dissolution testing.
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Vintage Pharmaceuticals LLC
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Presence of Particulate Matter
Presence of Particulate Matter
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
GC Natural Nutrition
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.