Drug recall
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for…
FDA recall event 84754 · Class III · Macleods Pharma Usa Inc
Key facts
| Event ID | 84754 |
|---|---|
| Recall numbers | D-0838-2020 |
| Recalling firm | Macleods Pharma Usa Inc |
| Product type | Drugs |
| Products | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. |
| Initiation date | Jan 24, 2020 |
| Report date | Feb 12, 2020 |
| Termination date | Dec 16, 2022 |
| City | Plainsboro |
| State | NJ |
| Country | United States |
| FEI number | 3009750394 |
At a glance
- 1–9 Products in this recall
- None 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: