Drug product
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
D-0857-2016
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 73913
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68, 214 bottles
- Official record key
drug-enforcement:D-0857-2016
Official wording
Reason: Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Code information: Lot #: M25569, Exp 08/18
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.