Drug recall D-0626-2021
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 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
Lots and codes
Lot EG6023, Exp. 07/01/2022
Recall details
- Recalling firm
- PFIZER, INC, Lake Forest, IL
- Quantity
- 163,957 vials
- Distribution
- Nationwide in the USA, Puerto Rico, and Guam
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 3, 2021
- Terminated
- April 4, 2023
Related products
- Bupivacaine Hydrochloride – drug information
- NDC 0409-1159 Bupivacaine Hydrochloride · Bupivacaine Hydrochloride 2.5 mg/mL · Hospira, Inc.
- NDC 0409-9045 Bupivacaine Hydrochloride and Epinephrine · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate 5… · Hospira, Inc.
- NDC 0409-1162 Bupivacaine Hydrochloride · Bupivacaine Hydrochloride 5 mg/mL · Hospira, Inc.
- NDC 0409-9043 Bupivacaine Hydrochloride and Epinephrine · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Hospira, Inc.
- NDC 0409-1163 Bupivacaine Hydrochloride · Bupivacaine Hydrochloride 5 mg/mL · Hospira, Inc.
- NDC 0409-1165 Bupivacaine Hydrochloride · Bupivacaine Hydrochloride 7.5 mg/mL · Hospira, Inc.
- NDC 0409-9046 Bupivacaine Hydrochloride and Epinephrine · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate 5… · Hospira, Inc.
- NDC 0409-9042 Bupivacaine Hydrochloride and Epinephrine · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Hospira, Inc.
- NDC 0409-1160 Bupivacaine Hydrochloride · Bupivacaine Hydrochloride 2.5 mg/mL · Hospira, Inc.