Drug recall
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use…
FDA recall event 67155 · Class II · Betachem, Inc.
Key facts
| Event ID | 67155 |
|---|---|
| Recall numbers | D-406-2014 |
| Recalling firm | Betachem, Inc. |
| Product type | Drugs |
| Products | Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices. |
| Initiation date | Oct 7, 2013 |
| Report date | Jan 22, 2014 |
| Termination date | Aug 7, 2017 |
| City | Upper Saddle River |
| State | NJ |
| Country | United States |
| FEI number | 3001452923 |
At a glance
- 1–9 Products in this recall
- 1–9 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: