Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Product description
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Lot numbers, UPCs & expiration codes
JKP0905A 04/17
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-0446-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 20, 2016
- FDA report date
- Feb 1, 2017
- Quantity
- 11,618 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0446-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76282
- Address
- 270 Prospect Plains Rd
- Code information
- JKP0905A 04/17
- Postal code
- 08512-3605
- Report date
- Feb 1, 2017
- Product type
- Drugs
- Recall number
- D-0446-2017
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 11,618 bottles
- Termination date
- Jul 11, 2018
- Reason for recall
- Failed Dissolution Specifications; 18 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 20, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 25, 2017