Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) 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) 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; b) 020116-2, Exp. 12/13/2020; 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; c) 020116-1, 020116-2, Exp. 12/13/2020; 021115-1, exp. 01/15/2020; 080415-1, Exp. 03/22/2020; 082416-1, 082416-2 Exp. 01/31/2021.
- 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:
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Product Codes/Lot Numbers:
Lot #: a) 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; b) 020116-2, Exp. 12/13/2020; 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; c) 020116-1, 020116-2, Exp. 12/13/2020; 021115-1, exp. 01/15/2020; 080415-1, Exp. 03/22/2020; 082416-1, 082416-2 Exp. 01/31/2021.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0506-2018
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