D-0076-2021 Class II Terminated
FDA drug recall D-0076-2021 was initiated by Baxter Healthcare Corporation on October 7, 2020 and is designated Class II. Reason for recall: Presence of particulate matter in solution - black and transparent particles The recall status is terminated (terminated May 22, 2023).
Recall Details
- Product Type
- Drugs
- Report Date
- November 18, 2020
- Initiation Date
- October 7, 2020
- Termination Date
- May 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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
Distribution Pattern
Nationwide USA
Code Information
Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022