Zoloft Solution, Concentrate
FDA Recall NDC 0049-0050
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Zoloft (NDC 0049-0050). A significant event, classified as Class II, was initiated on Oct 20, 2017 by Roerig. The reported reason for this action was: "SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Oct 20, 2017
Jan 10, 2018
1972 bottles
Recall Profile & Regulatory Data
Event ID
78332
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 02, 2020
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
Batch or Lot Expiration Information
Lot# Lot: S84026
Affected Packages Involved in this Recall
0049-4960-30Product
0049-4960-50Product
0049-4900-30Product
0049-4900-66Product
0049-4900-73Product
0049-4900-94Product
0049-4900-41Product
0049-4910-30Product
0049-4910-66Product
0049-4910-73Product
0049-4910-94Product
0049-4910-41Product
0049-0050-01Product
Class II Terminated
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Apr 28, 2016
Jun 01, 2016
68, 214 bottles
Recall Profile & Regulatory Data
Event ID
73913
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jul 26, 2017
Product Description
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
Affected Packages Involved in this Recall
0049-4960-30Product
0049-4960-50Product
0049-4900-30Product
0049-4900-66Product
0049-4900-73Product
0049-4900-94Product
0049-4900-41Product
0049-4910-30Product
0049-4910-66Product
0049-4910-73Product
0049-4910-94Product
0049-4910-41Product
0049-0050-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
