🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: February 4, 2013 American Health Packaging Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
American Health Packaging
Reason for Recall:
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-892-2013

Related Recalls

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

American Health Packaging

Class I - Dangerous

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

May 3, 2022 Prescription Drugs Nationwide View Details →