FDAFDA · Food and drugs·Recall number D-0246-2015
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Published November 19, 2014 · Recall initiated: August 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro Labs Usa, Inc S
- Distributor
- NY
- Lot
- Lot #: STBG005, Exp 2/2015
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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