Recalls / Class III
Class IIID-0769-2016
Product
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
- Affected lot / code info
- Lot #GS009075; Exp. 09/17 Lot #GS009763; Exp. 09/17 Lot #GS010178; Exp. 10/17
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 172 100-count packages (17,200 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-01-27
- FDA classified
- 2016-03-09
- Posted by FDA
- 2016-03-16
- Terminated
- 2016-06-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0769-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.