Recalls / Class III
Class IIID-0149-2017
Product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
- Brand name
- Bupropion
- Generic name
- Bupropion
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 68382-353, 68382-354
- FDA application
- ANDA201567
- Affected lot / code info
- Lot #: MR3365, Exp. Feb 17
Why it was recalled
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 2,472 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-03
- FDA classified
- 2016-11-22
- Posted by FDA
- 2016-11-30
- Terminated
- 2018-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0149-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.