FDAClass IOctober 25, 2023

Sucralfate Oral Suspension recall: Sterility Concern

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

Why was Sucralfate Oral Suspension recalled?

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 810300, Exp 10/2023

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
Recalling firm
VistaPharm LLC
Quantity
180 bottles
Distribution
USA Nationwide
Recall date
October 25, 2023
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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