Prescription and over-the-counter medications
Gyma Laboratories Of Amer,Inc
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Valeant Pharmaceuticals International
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Sagent Pharmaceuticals
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Astellas Pharma US
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Janssen Ortho L.L.C.
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Defective Container: Product leaks when inverted.
Unique Pharmaceutical
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Zydus Pharmaceuticals USA
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Unique Pharmaceutical
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Mylan Pharmaceuticals
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Actavis Laboratories, FL
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Lack of Assurance of Sterility; leaking of premix bags
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Baxter Healthcare
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.