One Lot of Pravastatin Sodium Tablets and 13 Lots of Lorazepam Oral Concentrate Recalled – APhA submits compounding comments to FDA. – (866) 348-2889
International Laboratories, LLC, is recalling one lot of pravastatin sodium tablets, USP 40 mg that are packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The recalled product is labeled as pravastatin sodium tablets USP 40 mg, but contained bupropion hydrochloride XL 300 mg tablets. The affected National Drug Code (NDC) is 54458-925-16 and the lot number is 115698A. The lot was recalled after a pharmacist informed International Laboratories that one 30-count bottle of pravastatin sodium tablets USP 40 mg was mislabeled and contained bupropion hydrochloride XL 300 mg tablets, indicates a safety alert posted to FDA’s website.
Amneal Pharmaceuticals, LLC, is recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings. The recalled product was distributed nationwide to wholesalers and is packaged with a dosing dropper supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings, or has dose markings that are shifted.