Recalls / Class III
Class IIID-0246-2015
Product
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
- Brand name
- Simvastatin
- Generic name
- Simvastatin
- Active ingredient
- Simvastatin
- Route
- Oral
- NDCs
- 42571-005, 42571-010, 42571-020, 42571-040, 42571-080
- FDA application
- ANDA090383
- Affected lot / code info
- Lot #: STBG005, Exp 2/2015
Why it was recalled
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Recalling firm
- Firm
- Micro Labs Usa, Inc S
- Manufacturer
- Micro Labs Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 104 Carnegie Ctr, Te 216, Princeton, New Jersey 08540-6232
Distribution
- Quantity
- 1,008 bottles
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2014-08-19
- FDA classified
- 2014-11-12
- Posted by FDA
- 2014-11-19
- Terminated
- 2016-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0246-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.