Recalls / Class III
Class IIID-0007-2017
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 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
- JKN5124A and JKN5229A, exp 10/2016
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 31,762 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-13
- FDA classified
- 2016-10-06
- Posted by FDA
- 2016-10-12
- Terminated
- 2018-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.