April 2020 FDA Recall Drug by B. Braun Medical Inc
D-1257-2020 - Failed Stability Specifications
This Class I drug recall was voluntarily initiated by B. Braun Medical Inc on April 18, 2020 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1257-2020
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
04-18-2020
05-06-2020
22,488 Duplex containers
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B. Braun Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide within the United States.
10-21-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
Batch or Lot Expiration Information
Lot# : H8J812, Exp. Date 31 JUL 2020
