Reported Mar 18, 2015 · Terminated
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only,…
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, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only
- Manufactured byMicro Labs Limited Goa-403 722, India
- Manufactured forMicro Labs USA Inc.,Princeton, NJ 08540
- Lot codes and dates
Lot #: STCG005Exp 01/2015Lot #: STCG011Exp 03/2015Lot #: STCG012Exp 02/2015
- Amount recalled
- 240 (1000-count bottle), 26,904 (90-count bottle)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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