Drug recall
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC…
FDA recall event 92900 · Class III · Caplin Steriles Limited
Key facts
| Event ID | 92900 |
|---|---|
| Recall numbers | D-1144-2023 |
| Recalling firm | Caplin Steriles Limited |
| Product type | Drugs |
| Products | Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Aug 14, 2023 |
| Report date | Sep 13, 2023 |
| Termination date | Sep 9, 2025 |
| City | Gummidipoondi |
| Country | India |
| FEI number | 3005035920 |
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: