APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16
- 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:
- Valeant Pharmaceuticals North America LLC
- Reason for Recall:
- Labeling: Incorrect or Missing Package Insert
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
Product Codes/Lot Numbers:
Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0053-2015
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