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Terminated

15776-20 REG ANES W/DRUGS

FDA Recall Z-1258-04 · Posted 2004-07-30

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeCAZ
Date Initiated2004-07-02
Date Terminated2006-05-02
Product Quantity200 units

Reason for Recall

Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.

Firm Action

Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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