PFIZER, INC: 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc

Is my product affected?

1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

• Brand LIDOCAINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Pfizer is recalling 1% Lidocaine HCl Injection vials due to a labeling mix-up affecting 139,050 vials nationwide. Some vials labeled as containing 0.5% Bupivacaine Hydrochloride Injection actually contain 1% Lidocaine HCl Injection, while some vials labeled as containing 1% Lidocaine HCl Injection actually contain 0.5% Bupivacaine Hydrochloride Injection. The affected product is NDC 0409-4279-16 (30 mL single-dose vials) distributed in trays of 25 vials (NDC 0409-4279-02), with Lot EG8933 expiring 08/01/2022, and was distributed in the USA, Puerto Rico, and Guam.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Details from the source

Reason for recall: Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP Distribution: Nationwide in the USA, Puerto Rico, and Guam Quantity: 139,050 vials Lot/code info: Lot EG8933, Exp. 08/01/2022

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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