Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot JKN3477A, exp 07/2016
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-1446-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 27, 2016
- FDA report date
- Jul 27, 2016
- Quantity
- 16,085 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-1446-2016, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74696
- Address
- 270 Prospect Plains Rd
- Code information
- Lot JKN3477A, exp 07/2016
- Postal code
- 08512-3605
- Report date
- Jul 27, 2016
- Product type
- Drugs
- Recall number
- D-1446-2016
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 16,085 bottles
- Termination date
- Mar 27, 2018
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 20, 2016