October 2023 FDA Recall Sucralfate by Vistapharm Llc
D-0047-2024 - Microbial Contamination of Non-Sterile Products
This Class I drug recall was voluntarily initiated by Vistapharm Llc on October 18, 2023 for the product Sucralfate. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0047-2024
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
10-18-2023
10-25-2023
180 bottles
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.
VistaPharm LLC
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.
USA Nationwide
04-30-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
Batch or Lot Expiration Information
Lot# : 810300, Exp 10/2023
