Why it was recalled
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Product description
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
Lot numbers, UPCs & expiration codes
Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
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-1513-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 14, 2014
- FDA report date
- Aug 13, 2014
- Quantity
- 840 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1513-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68813
- Address
- 20 Waterview Blvd., Suite 3
- Code information
- Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
- Postal code
- 07054
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1513-2014
- Classification
- Class III
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 840 bottles
- Termination date
- Jan 12, 2015
- Reason for recall
- Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2014