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

FDA recall notice · announced November 18, 2020 · Baxter Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Presence of particulate matter in solution - black and transparent particles

Notes

Distribution: Nationwide USA
Lot/code information: Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022
Status: Terminated
Products in this recall event:
- 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, Ma (D-0076-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.