Drug recall
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of…
FDA recall event 73913 · Class II · Pfizer Inc.
Key facts
| Event ID | 73913 |
|---|---|
| Recall numbers | D-0857-2016 |
| Recalling firm | Pfizer Inc. |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. |
| Initiation date | Apr 28, 2016 |
| Report date | Jun 1, 2016 |
| Termination date | Jul 26, 2017 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 2416101 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: