Recall: D-0626-2021

Class I - Dangerous

Class IClassification

2021-05-03Initiated

TerminatedStatus

PFIZER, INCFirm

Product

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.

Reason

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.