D-0151-2018 Class II Terminated
FDA drug recall D-0151-2018 was initiated by Pfizer Inc. on October 20, 2017 and is designated Class II. Reason for recall: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent The recall status is terminated (terminated June 2, 2020). Affected quantity: 1972 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2018
- Initiation Date
- October 20, 2017
- Termination Date
- June 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1972 bottles
Product Description
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
Reason for Recall
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Distribution Pattern
Nationwide in the USA
Code Information
Lot: S84026