Why it was recalled
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Product description
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Lot numbers, UPCs & expiration codes
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
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-892-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 4, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 389 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-892-2013, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 65457
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
- Postal code
- 43217-1188
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-892-2013
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 389 cartons
- Termination date
- Aug 28, 2013
- Reason for recall
- Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2013