TOPIC: Sucralfate Tablets USP, 1 Gram by Nostrum Laboratories: Recall - Due to Company Closure and Discontinuation of Quality Activities
AUDIENCE: Patient, Health Care Professional, Pharmacy, Gastroenterology
ISSUE: Nostrum Laboratories, Inc.is initiating a recall of Sucralfate Tablets USP, 1 gram, all lots within expiry, as a result of the closures and discontinuation of its quality activities.
This recall pertains only to Sucralfate Tablets USP, 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. No other Nostrum Labs products are affected by this recall. Nostrum Labs distributed the product at issue here to wholesalers, retailers, manufacturers, medical facilities, and repackagers.
It cannot be guaranteed that any lots of this product that are still within expiry will meet all intended specifications through the labeled shelf life of the product.
Risk Statement: The discontinuation of Nostrum Labs’ quality program means that the company is unable to assure that this product meets the identity, strength, quality, and purity characteristics that it is purported or represented to possess. While specific risks to patients from use of an adulterated product cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such a product.
Nostrum Labs has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Nostrum Laboratories, Inc. filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites.
RECOMMENDATIONS:
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Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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All lots of this product should be destroyed; Nostrum Labs is not accepting any returns of this product.
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Nostrum Labs is notifying its distributors and direct consignees for this product by email and U.S. mail and is requesting they immediately further notify their subsidiaries, individual receiving sites or warehouses, customers, retailers, and consumers.
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Further distribution or use of any remaining product on the market should cease immediately.
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Customers with questions regarding this recall can contact Nostrum Labs at recallcoordinator@nostrumlabsrecall.com.
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