Reported Nov 19, 2014 · Terminated
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA,…
Micro Labs USA, Inc. S
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro Labs Usa, Inc S · 104 Carnegie Ctr · Princeton, NJ · 08540-6232
Is this the product you have?
- Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles
- Manufactured byMicro Labs Limited, Goa-403 722, INDIA
- Manufactured forMicro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
- Lot codes and dates
Lot #: STBG005Exp 2/2015
- Amount recalled
- 1,008 bottles
Where it was sold
Why it was recalled
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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