Recalls / Class II
Class IID-0857-2016
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.
- 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 #: M25569, Exp 08/18
Why it was recalled
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
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
- 68, 214 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-04-28
- FDA classified
- 2016-05-20
- Posted by FDA
- 2016-06-01
- Terminated
- 2017-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0857-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.