Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), 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) 072915-1, Exp. 07/05/2019; b) 072915-1, Exp. 07/05/2019
- 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:
Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Product Codes/Lot Numbers:
Lot #: a) 072915-1, Exp. 07/05/2019; b) 072915-1, Exp. 07/05/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0504-2018
Related Recalls
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
American Pharmaceutical Ingredients
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
American Pharmaceutical Ingredients
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
American Pharmaceutical Ingredients
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.