Nostrum Labs, which declared bankruptcy last year and has since ceased operations, issued a voluntary recall for all lots of its 1-gram sucralfate tablets that are used to treat ulcers.
The recall was announced in a press release posted on the FDA’s enforcement website and covers “all lots” with a future expiration date that were produced by the formerly Missouri- and New Jersey-based company after June of 2023.
“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 company said in the July 11 notice.
Nostrum did not disclose the number of lots being recalled. To date, the company has not received any reports of adverse events related to the drug lots, which were distributed nationwide.
The company is not accepting any returns of the product and is advising that all lots should be destroyed.
In October of 2023, the company settled a dispute with the U.S. Attorney’s Office in the District of Massachusetts for allegedly failing to pay the required rebate amounts owed for Nitro OS (used to treat and prevent angina) under Medicaid programs.
More recently, Nostrum declared bankruptcy in September of 2024.
Nostrum was among a number of companies involved in the 2020-21 mass recall of the diabetes drug metformin due to the presence of higher-than-allowed levels of the possible carcinogen N-nitrosodimethylamine (NDMA). Nostrum issued at least two recalls related to that product.