Recalls / Class III
Class IIID-0407-2015
Product
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
- Affected lot / code info
- Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.
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
- 240 (1000-count bottle), 26,904 (90-count bottle)
- 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-0407-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.