Recalls / Class II
Class IID-0151-2018
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
- Brand name
- Zoloft
- Generic name
- Sertraline Hydrochloride
- Active ingredient
- Sertraline Hydrochloride
- Route
- Oral
- NDCs
- 0049-0050, 0049-4960, 0049-4900, 0049-4910
- FDA application
- NDA020990
- Affected lot / code info
- Lot: S84026
Why it was recalled
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- ROERIG
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 1972 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-20
- FDA classified
- 2018-01-04
- Posted by FDA
- 2018-01-10
- Terminated
- 2020-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0151-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.