Recalls / Class III
Class IIID-1345-2015
Product
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 47335-736, 47335-737, 47335-738
- FDA application
- ANDA078866
- Affected lot / code info
- Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Why it was recalled
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Recalling firm
- Firm
- Sun Pharma Global Fze
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Office # 43 Block Y Saif Zone, Sharm, N/A, United Arab Emirates
Distribution
- Quantity
- 35,235 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2015-08-14
- Posted by FDA
- 2015-08-26
- Terminated
- 2016-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1345-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.