BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: 524099M, 524100A, 521687A
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Actavis Inc
- Reason for Recall:
- Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
- 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 Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Product Codes/Lot Numbers:
Lots: 524099M, 524100A, 521687A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1043-2014
Related Recalls
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.