Recalls / Class III
Class IIID-0408-2015
Product
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.
- Affected lot / code info
- Lot #: STDG010, Exp 3/2015
Why it was recalled
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Recalling firm
- Firm
- Micro Labs Usa, Inc S
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 104 Carnegie Ctr, Te 216, Princeton, New Jersey 08540-6232
Distribution
- Quantity
- 13488 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-12-04
- FDA classified
- 2015-03-11
- Posted by FDA
- 2015-03-18
- Terminated
- 2018-04-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0408-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.