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
Reported: November 18, 2020 Initiated: October 7, 2020 #D-0076-2021
Product Description
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
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Distribution
- Nationwide USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Baxter Healthcare Corporation.
Why was this product recalled? ▼
Presence of particulate matter in solution - black and transparent particles
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 18, 2020. Severity: Moderate. Recall number: D-0076-2021.
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