Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015
- 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:
- Micro Labs Usa, Inc S
- Reason for Recall:
- Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Product Codes/Lot Numbers:
Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0409-2015
Related Recalls
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
Micro Labs Usa, Inc S
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.