Recalls / Class III
Class IIID-1446-2016
Product
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
- 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 JKN3477A, exp 07/2016
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 16,085 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-27
- FDA classified
- 2016-07-20
- Posted by FDA
- 2016-07-27
- Terminated
- 2018-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1446-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.