Class III
Terminated
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
- Company
- Micro Labs Usa, Inc S
- Recall Initiated
- August 19, 2014
- Posted
- November 19, 2014
- Recall Number
- D-0246-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,008 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Distribution
NY
Lot / Code Info
Lot #: STBG005, Exp 2/2015
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