Nostrum Laboratories is recalling one of its medications, following the company’s closure due to bankruptcy.
Nostrum is recalling its Sucralfate Tablets USP 1 gram, which were manufactured after June 2023 and are all within its expiry period, according to the Food and Drug Administration (FDA).
Sucralfate is commonly used to treat ulcers, according
to WebMD
.
The products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities and repackagers. No other Nostrum Labs products are affected by this recall.
“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,“ the FDA wrote. ”Further distribution or use of any remaining product on the market should cease immediately.”
Distributors and direct consignees for the tablets have been asked to notify their subsidiaries, individual receiving sites or warehouses, customers and retailers.
Nostrum Labs is not accepting any returns and urges all lots of this product to be “destroyed.”
“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,” the company wrote in a statement. “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.”
No reports of “adverse events” related to the recall have been made to Nostrum Labs. Those who have experienced problems that could be related to taking or using the drug are urged to contact their physician or healthcare provider.
