WhichRecall
Class IIReported 2025-09-03

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 in September 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-0598-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-07-29
Reported
2025-09-03
Distribution
Nationwide
Code Info
Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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