FDA-Drug2020-11-18Class II

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

Baxter Healthcare Corporation
Hazard

Presence of particulate matter in solution - black and transparent particles

Sold states
Nationwide USA
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2021

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