Drug product
Atorvastatin Calcium 80 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 # 60429-326-77
D-0770-2016
Product summary
- Event
- Event 73152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 168 100-count packages (16,800 tablets)
- Official record key
drug-enforcement:D-0770-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #GS005603; Exp. 10/15 Lot #GS006691; Exp. 08/17 Lot #GS009073; Exp. 08/17 Lot #GS009395; Exp. 08/17 Lot #GS009764; Exp. 10/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications