April 2016 FDA Recall Zoloft by Pfizer Inc.
D-0857-2016 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Pfizer Inc. on April 28, 2016 for the product Zoloft. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0857-2016
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
04-28-2016
06-01-2016
68, 214 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
07-26-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : M25569, Exp 08/18
