Amerisource Health Services recalls certain Sucralfate Tablets due to CGMP deviations affecting product quality. Products may not meet identity, strength, or purity standards, posing potential safety risks.
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.
Amerisource Health Services is recalling specific Sucralfate Tablets because the manufacturing process had deviations that could mean the medication isn't safe or effective. This recall is due to the company filing for Chapter 11 bankruptcy in September 2024, which prevents them from ensuring product quality.
The recall is triggered by the company filing for Chapter 11 bankruptcy in September 2024, which means they can no longer monitor the quality of the medication. This could result in products that don't meet the required identity, strength, quality, or purity standards, making them potentially unsafe.
Prescription patients who received these specific Sucralfate Tablets from the recalled lots are affected. Those with medical conditions requiring this medication are at higher risk due to potential quality issues.
Check the product label for the NDC code 60687-695-01, lot numbers 1015038, 1015898, 1016873, or 1023398, and expiration dates up to July 31, 2026.
Identify the NDC code 60687-695-01 and lot numbers 1015038, 1015898, 1016873, or 1023398 on the medication packaging.
The manufacturer filed for Chapter 11 bankruptcy in September 2024, which means they can no longer ensure the medication meets quality standards, potentially making it adulterated.
The official recall notice does not specify a remedy, so check with your healthcare provider or pharmacist for guidance.
Yes, avoid lot numbers 1015038 (exp 07/31/2025), 1015898 (exp 09/30/2025), 1016873 (exp 10/31/2025), and 1023398 (exp 07/31/2026).
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0598-2025 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0598-2025 from Amerisource Health Services. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
