BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA

FDA recall notice · announced December 28, 2016 · Zydus Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Reason for recall

Failed Dissolution Specifications; 6 month time point

Notes

Distribution: Nationwide
Lot/code information: a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
Quantity: 16,356 bottles
Status: Terminated
Products in this recall event:
- BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahme (D-0207-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.