Drug recall
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ…
FDA recall event 81554 · Class III · RemedyRepack Inc.
Key facts
| Event ID | 81554 |
|---|---|
| Recall numbers | D-0245-2019 |
| Recalling firm | RemedyRepack Inc. |
| Product type | Drugs |
| Products | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. |
| Initiation date | Oct 26, 2018 |
| Report date | Nov 21, 2018 |
| Termination date | Feb 5, 2019 |
| City | Indiana |
| State | PA |
| Country | United States |
| FEI number | 3005841768 |
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: