PFIZER, INC: Drug Recall

Recall #D-0627-2021 · 05/03/2021

Class I: Dangerous

Recall Details

Recall Number
D-0627-2021
Classification
Class I
Product Type
Drug
Recalling Firm
PFIZER, INC
Status
Terminated
Date Initiated
05/03/2021
Location
Lake Forest, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
139,050 vials

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

Product Description

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.

Distribution Pattern

Nationwide in the USA, Puerto Rico, and Guam

Other Recalls by PFIZER, INC

View all recalls by PFIZER, INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.