Drug recall
L-Cysteine Hydrochloride Injection, USP 50 mg/ml ( 10 ml fill in 10 ml vials, package of 10 vials.; NDC#…
FDA recall event 55595 · Class II · Teva Pharmaceuticals USA
Key facts
| Event ID | 55595 |
|---|---|
| Recall numbers | D-802-2010, D-803-2010 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | L-Cysteine Hydrochloride Injection, USP 50 mg/ml ( 10 ml fill in 10 ml vials, package of 10 vials.; NDC# 0703-5324-03); 10 ml vials, individual vial; NDC# 0703-5324-01).The lots were distributed under…, L-Cysteine Hydrochloride Injection, USP 50 mg/ml (50 ml fill in 50 ml vials , package of 10 vials. NDC# 0703-5328-03) and (10 ml vials, individual vial- NDC# 0703-5328-01) The lots were distributed… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviation: Absence of stability indicating methods for assay and impurities. |
| Initiation date | Apr 28, 2010 |
| Termination date | Jul 14, 2012 |
| City | North Wales |
| State | PA |
| Country | United States |
| FEI number | 3003092769 |
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