Why it was recalled
Failed Dissolution Specifications; during stability testing
Product description
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Lot numbers, UPCs & expiration codes
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Where it was sold
Nationwide in the U.S.A
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-0761-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 9, 2023
- FDA report date
- May 31, 2023
- Quantity
- 5,344 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0761-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92289
- Address
- 2 Independence Way
- Code information
- Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
- Postal code
- 08540-6620
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0761-2023
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 5,344 Bottles
- Termination date
- Feb 27, 2024
- Reason for recall
- Failed Dissolution Specifications; during stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
- Distribution pattern
- Nationwide in the U.S.A
- Recall initiation date
- May 9, 2023
- Initial firm notification
- Letter
- Center classification date
- May 23, 2023