Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Compare with the code on your package — it is the most precise check available.
Drug: Sucralfate
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Labeling: Label Mix-Up
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Failed tablet specifications.
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
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