Drug 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.
D-0626-2021
Product summary
- Firm
- PFIZER, INC
- Event
- Event 87837
- Status
- Terminated
- Classification
- Class I
- Quantity
- 163,957 vials
- Official record key
drug-enforcement:D-0626-2021
Official wording
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
Code information: Lot EG6023, Exp. 07/01/2022
Distribution pattern: Nationwide in the USA, Puerto Rico, and Guam
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up