Drug recall
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc…
FDA recall event 76120 · Class III · Hetero Drugs Ltd. - Unit 1
Key facts
| Event ID | 76120 |
|---|---|
| Recall numbers | D-0453-2017 |
| Recalling firm | Hetero Drugs Ltd. - Unit 1 |
| Product type | Drugs |
| Products | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product. |
| Initiation date | Dec 29, 2016 |
| Report date | Feb 8, 2017 |
| Termination date | Jul 11, 2017 |
| City | Medak District |
| Country | India |
| FEI number | 3003510514 |
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: