Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), 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) 092415-1, Exp. 05/21/2018; b) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018; c) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018 d) 092415-1, Exp. 05/21/2018;
- 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:
Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Product Codes/Lot Numbers:
Lot #: a) 092415-1, Exp. 05/21/2018; b) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018; c) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018 d) 092415-1, Exp. 05/21/2018;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0501-2018
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