Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
JKN5124A and JKN5229A, exp 10/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0007-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 13, 2016
- FDA report date
- Oct 12, 2016
- Quantity
- 31,762 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0007-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75206
- Address
- 270 Prospect Plains Rd
- Code information
- JKN5124A and JKN5229A, exp 10/2016
- Postal code
- 08512-3605
- Report date
- Oct 12, 2016
- Product type
- Drugs
- Recall number
- D-0007-2017
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 31,762 bottles
- Termination date
- Jul 2, 2018
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 13, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 6, 2016