Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Sucralfate
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sucralfate NDC 66689-0305 |
1 g/10mL | Suspension Oral |
VistaPharm, LLC | Rx |
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Labeling: Label Mix-Up
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Failed Excipient Specifications: high content of ethylene glycol (EG)
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
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