Sucralfate

NEW YORK, DC, UNITED STATES, July 11, 2025 / EINPresswire.com / -- Nostrum Laboratories, Inc. (“Nostrum Labs”) 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. Nostrum Labs is initiating a voluntary 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. Further distribution or use of any remaining product on the market should cease immediately. 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. All lots of this product should be destroyed; Nostrum Labs is not accepting any returns of this 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. Customers with questions regarding this recall can contact Nostrum Labs at recallcoordinator@nostrumlabsrecall.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. • Complete and submit the report online: www.fda.gov/medwatch/report.htm • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Recall Coordinator Nostrum Labs Recall recallcoordinator@nostrumlabsrecall.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

New Delhi: During the routine quality review check in March, a total of 131 drug samples failed to meet the quality standards, while one sample of the popular hypertension brand Telma 40 has been flagged as spurious. The monthly drug quality review alert issued by the Central Drugs Standard Control Organization (CDSCO) flagged 131 drug samples as “ Not of Standard Quality ” (NSQ) and one sample as “spurious.” Making the announcement, the Union Health Ministry informed that of the total 131 NSQ samples, 70 were identified by the Central Drugs Laboratories and the remaining 61 samples were identified by the State Drugs Testing Laboratories. In addition to this, one drug sample flagged as spurious is of popular hypertension brand “Telma 40 (Telmisartan Tab I.P. 40mg),” manufactured in February 2024 and was plucked by the regulators from West Bengal. As per the Union Health Ministry, “the spurious sample was manufactured by an unauthorized manufacturer using a brand name owned by another company, and currently the matter is under investigation.” In its remark, the apex drug regulator CDSCO has said, “the product is purported to be spurious, however, the same is subject to the outcome of investigation.” Notably, last month a separate batch of the same brand picked from West Bengal was flagged as spurious. The sample was manufactured in 2022, and the reason for the drug test failure was notified as the sample “does not conform to I.P.” Telma (Telmisartan) is an angiotensin II receptor blocker that decreases high blood pressure and has been commercially marketed in India for the past two decades. The branded generic drug is marketed by Glenmark and, as per an analysis from market research firm Pharmarack, it features among the top 20 brands in the country, with a moving annual total (MAT) value of around ₹483 crore. The NSQ drug samples flagged by the central drug laboratories in March include Pantoprazole manufactured by Kolkata-based Shangrila Industries; Albendazole tablets by Mumbai-based Digital Vision; Telmisartan tablets manufactured by Guwahati-based Swiss Garnier Life Sciences; among 67 others. While the NSQ samples identified by state drug testing laboratories include Norfloxacin tablets manufactured by Revat Laboratories; Glimepiride tablets by Kerala State Drugs and Pharmaceuticals; Sucralfate by Legend Industries; among 58 others. Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug shall be deemed spurious if it is manufactured under a name belonging to another drug; an imitation of, or a substitute for, another drug; resembles another drug in a manner likely to deceive; or if it bears upon its label or container the name of another drug, among several other provisions. For NSQ samples, the drugs that fail to meet quality standards or specifications are notified as NSQ, a term defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. By Online Bureau ,