PFIZER, INC: Drug Recall
Recall #D-0626-2021 · 05/03/2021
Class I: Dangerous
Recall Details
- Recall Number
- D-0626-2021
- 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
- 163,957 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
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.
Distribution Pattern
Nationwide in the USA, Puerto Rico, and Guam
Other Recalls by PFIZER, INC
- Class II: Risk 08/04/2025
- Class II: Risk 08/04/2025
- Class II: Risk 07/10/2025
- Class II: Risk 07/10/2025
- Class II: Risk 05/28/2025
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.