WhichRecall
Class IIReported 2025-10-22

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]

Recalled by Amerisource Health Services LLC

Reason for Recall

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024

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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.

Recall Number
D-0027-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-09
Reported
2025-10-22
Distribution
Nationwide within the United States
Code Info
Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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