Drug 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
D-0769-2016
Product summary
- Event
- Event 73152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 172 100-count packages (17,200 tablets)
- Official record key
drug-enforcement:D-0769-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #GS009075; Exp. 09/17 Lot #GS009763; Exp. 09/17 Lot #GS010178; Exp. 10/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications