Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals…
Reason Failed Tablet/Capsule Specifications
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Moisture Limits: Product tested out-of-specification for moisture content.
BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Tablet/Capsule Specifications
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Reason Presence of Foreign Tablets/Capsules
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
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