Levomefolate calcium

WEDNESDAY, Aug. 2, 2023 -- Certain lots of the prescription birth control pill Tydemy may be less effective than expected, potentially resulting in an unintended pregnancy, because the pills do not contain enough of an active ingredient. The U.S. Food and Drug Administration warned consumers about the issue Tuesday following a company announcement about the issue on July 29. Two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium) made by Lupin Pharmaceuticals do not contain the correct level of ascorbic acid, the FDA noted. Lots L200183 and L201560, in 28-dose blister packs, were distributed throughout the United States between June 3, 2022, and May 31, 2023. "To date, Lupin has received no reports of adverse events related to either recalled batches," the company noted. "Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy." Patients should continue taking their medication, the FDA said, but they should also immediately contact their health care provider for advice about an alternative method of birth control. The company had previously voluntarily recalled the two lots of Tydemy at the wholesale level. "Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 9:00 a.m. to 5:00 p.m. EST," Lupin instructed in its statement. "For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton." The FDA also encouraged health care providers and patients to report any adverse events or quality problems with this or other medications to the agency’s MedWatch Adverse Event Reporting program. Sources U.S. Food and Drug Administration, Aug. 1, 2023 Posted August 2023

BALTIMORE, Md, July 29, 2023 /PRNewswire/ --Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity. Continue Reading Product Pack (PRNewsfoto/Lupin Pharmaceuticals, Inc.) To date, Lupin has received no reports of adverse events related to either recalled lots. Regardless, Lupin is recalling two lots because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy. Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28's blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton. The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below: Lupin is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots. Patients taking, Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. 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: Regular Mail or Fax: Download form 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. Product Label: About Lupin Pharmaceuticals Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.'s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women's health conditions with serious health consequences. Photo - SOURCE Lupin Pharmaceuticals, Inc.