Recall: D-1095-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-13Initiated

TerminatedStatus

Mckesson Medical-Surgical Inc.Firm

Product

Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

Reason

cGMP deviations: Temperature abuse

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.