October 2020 FDA Recall Drug by Baxter Healthcare Corporation
D-0076-2021 - Presence of particulate matter in solution - black and transparent particles

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on October 7, 2020 for the product Drug. The FDA reported the reason for recall as presence of particulate matter in solution - black and transparent particles. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0076-2021

Reason for Recall
Presence of particulate matter in solution - black and transparent particles
Initiated
10-07-2020
Reported
11-18-2020
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86529
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-22-2023
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# : A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022