Drug product
Atorvastatin Calcium 10 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 # 60429-323-77
D-0767-2016
Product summary
- Event
- Event 73152
- Status
- Terminated
- Classification
- Class III
- Quantity
- 222 100-count packages (22,000 tablets)
- Official record key
drug-enforcement:D-0767-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #GS005602; Exp. 10/15 Lot #GS008855; Exp. 09/17 Lot #GS009074; Exp. 08/17 Lot #GS009393; Exp. 08/17 Lot #GS009760; Exp. 10/17 Lot #GS010599; Exp. 11/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications