Drug recall
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc…
FDA recall event 81017 · Class III · Hetero Labs, Ltd. - Unit III
Key facts
| Event ID | 81017 |
|---|---|
| Recall numbers | D-1211-2018 |
| Recalling firm | Hetero Labs, Ltd. - Unit III |
| Product type | Drugs |
| Products | Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg. |
| Initiation date | Sep 12, 2018 |
| Report date | Oct 3, 2018 |
| Termination date | Nov 29, 2018 |
| City | Hyderabad |
| Country | India |
| FEI number | 3005406526 |
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: