Drug recall
Carbocaine 1.5% mepivacaine hydrochloride injection USP, 15 mg/mL in 30 mL single dose vial, Rx only, Sterile…
FDA recall event 34501 · Class II · Hospira Inc.
Key facts
| Event ID | 34501 |
|---|---|
| Recall numbers | D-179-6, D-180-6, D-181-6, D-182-6, D-183-6, D-184-6, D-185-6, D-186-6 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | Carbocaine 1.5% mepivacaine hydrochloride injection USP, 15 mg/mL in 30 mL single dose vial, Rx only, Sterile Injection For peripheral nerve block, caudal and epidural anesthesia, Abbott Laboratories…, Carbocaine 2% mepivacaine hydrochloride injection USP, 20 mg/mL in 20 mL single dose vial and 50 mL multiple dose vials, Rx only, Sterile Injection, For peripheral nerve block, caudal and epidural…, Cefazolin for Injection (lyophilized), equivalent to 1 gram cefazolin; Single-dose ADD-Vantage Vial, 25 vials per carton, Rx only, For I.V. Infusion Only, Note: For use only with ADD-Vantage Flexible…, Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL single dose fliptop vial, 25 vials per carton, Rx only, For I.M. or I.V. Use, dilute before I.V. use; Hospira, Inc., Lake Forest, IL 60045…, Dobutamine Injection, USP, each mL contains 12.5 mg dobutamine, as the hydrochloride, 250 mg per 20 mL, 20 mL single-dose fliptop vial, 10 vials per carton, must be diluted prior to use, For I.V. Use… and 3 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Efficacy; affected lots were initially received in a frozen state. The labeling claim for these products does not support their use when frozen., Lack of Efficacy; the affected lots were initially received in a frozen state. The labeling claim for these products does not support their use when frozen, Lack of Efficacy; the affected lots were initially received in a frozen state. The… |
| Initiation date | Jan 24, 2006 |
| City | Lake Forest |
| Country | United States |
| FEI number | 3004572086 |
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