D-0626-2021 Class I Terminated
FDA drug recall D-0626-2021 was initiated by PFIZER, INC on May 3, 2021 and is designated Class I. 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 Injec… The recall status is terminated (terminated April 4, 2023). Affected quantity: 163,957 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 9, 2021
- Initiation Date
- May 3, 2021
- Termination Date
- April 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163,957 vials
Product Description
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 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 Pattern
Nationwide in the USA, Puerto Rico, and Guam
Code Information
Lot EG6023, Exp. 07/01/2022