Prescription and over-the-counter medications
Vintage Pharmaceuticals LLC
Failed Dissolution Specifications
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
South Coast Specialty Compounding
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Silarx Pharmaceutical
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
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.
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
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.