Drug product
Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
D-0151-2018
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 78332
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1972 bottles
- Official record key
drug-enforcement:D-0151-2018
Official wording
Reason: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Code information: Lot: S84026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
SUPERPOTENT