PFIZER, INC: 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distr

Is my product affected?

0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

• Brand BUPIVACAINE HYDROCHLORIDE

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

What happened

Pfizer is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a labeling mix-up. Some vials labeled as containing 0.5% Bupivacaine Hydrochloride Injection may actually contain 1% Lidocaine HCl Injection, and conversely, some vials labeled as 1% Lidocaine HCl Injection may contain 0.5% Bupivacaine Hydrochloride Injection. The affected product is packaged in 25-vial trays (NDC 0409-1162-02) and comes in 30 mL single-dose vials (NDC 0409-1162-19). The recall affects Lot EG6023 with an expiration date of July 1, 2022, and was distributed nationwide in the USA, Puerto Rico, and Guam.

The source document does not specify what actions affected consumers should take regarding this recall.

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: 163,957 vials Lot/code info: Lot EG6023, Exp. 07/01/2022

Source

Official record: FDA (Drug enforcement) ↗

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

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