Drug recall
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05)…
FDA recall event 80973 · Class III · InvaGen Pharmaceuticals, Inc.
Key facts
| Event ID | 80973 |
|---|---|
| Recall numbers | D-1212-2018 |
| Recalling firm | InvaGen Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b)… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count… |
| Initiation date | Sep 6, 2018 |
| Report date | Sep 26, 2018 |
| Termination date | Oct 22, 2020 |
| 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: