Drug recall
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc…
FDA recall event 88927 · Class II · SUN PHARMACEUTICAL INDUSTRIES INC
Key facts
| Event ID | 88927 |
|---|---|
| Recall numbers | D-0361-2022 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Product type | Drugs |
| Products | Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. |
| Initiation date | Oct 22, 2021 |
| Report date | Jan 12, 2022 |
| Termination date | Apr 6, 2023 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3013472760 |
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: