Recalls / Class II
Class IID-0076-2021
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
- Affected lot / code info
- Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022
Why it was recalled
Presence of particulate matter in solution - black and transparent particles
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2020-10-07
- FDA classified
- 2020-11-12
- Posted by FDA
- 2020-11-18
- Terminated
- 2023-05-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0076-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.