Drug recall
Pancuronium Bromide Injection 10mg/10 mL (1 mg/mL)10 mL Multiple Dose Vial (NDC 0703-2804-01), packaged in 10…
FDA recall event 55078 · Class III · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 55078 |
|---|---|
| Recall numbers | D-519-2010, D-520-2010, D-521-2010 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Pancuronium Bromide Injection 10mg/10 mL (1 mg/mL)10 mL Multiple Dose Vial (NDC 0703-2804-01), packaged in 10 Vials per carton (NDC 0703-2804-03), Rx only. The lots were distributed under both Sicor…, Pancuronium Bromide Injection 10 mg/5 mL (2 mg/mL) 5 mL Multiple Dose Vial (NDC 0703-2823-01), packaged in 25 Vials per carton (NDC 0703-2823-04), Rx only. The lots were distributed under both Sicor…, Pancuronium Bromide Injection 4 mg/2 mL (2 mg/mL) 2 mL Vials (NDC 0703-2812-01), packaged in 25 Vials per carton (NDC 0703-2812-04), Rx only, The lots were distributed under both Sicor Pharmaceutical… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: These products are being recalled because they do not meet specification for related substances. |
| Initiation date | Mar 16, 2010 |
| Termination date | Jul 5, 2012 |
| City | Sellersville |
| State | PA |
| Country | United States |
| FEI number | 2517175 |
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