Drug recall
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla…
FDA recall event 79446 · Class III · InvaGen Pharmaceuticals, Inc.
Key facts
| Event ID | 79446 |
|---|---|
| Recall numbers | D-0618-2018, D-0619-2018 |
| Recalling firm | InvaGen Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by…, buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications; during stability testing |
| Initiation date | Mar 15, 2018 |
| Report date | Apr 11, 2018 |
| Termination date | Sep 15, 2021 |
| City | Hauppauge |
| State | NY |
| Country | United States |
| FEI number | 3003950641 |
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: