Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020;
- 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:
- American Pharmaceutical Ingredients LLC
- Reason for Recall:
- CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Product Codes/Lot Numbers:
Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0481-2018
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