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.
Reported: June 1, 2016 Initiated: April 28, 2016 #D-0857-2016
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.
Reason for Recall
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 68, 214 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pfizer Inc.. Units affected: 68, 214 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Moderate. Recall number: D-0857-2016.
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