03 August 2023 , 16:34
821
0
Two lots of Tydemy contraceptive tablets are being recalled as they were found to be potentially ineffective, resulting in unwanted pregnancies.
Lupin Pharmaceuticals Inc. is recalling two lots of Tydemy (Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) after the company detected out-of-specification (OOS) test results during the 12-month stability check.
The affected lots were found to contain "low levels of ascorbic acid, an inactive ingredient, and high levels of a known impurity," the company said. Lupin stated that there have been no reported adverse events related to the recalled batches so far. However, to ensure consumer safety, the company proceeds to recall the product.
It was found that the tablets could be ineffective due to low quantity of an inactive ingredient (Getty Images)A reduction in the amount of inactive content, such as ascorbic acid (Vitamin C), could impact the effectiveness of the oral contraceptive, leading to an increased risk of unexpected pregnancies, according to the company.
Tydemy is an estrogen/progestin oral contraceptive (COC) designed for women to prevent pregnancy and elevate folate levels in those who choose to use an oral contraceptive. The product is packaged in blisters of 28 tablets each, with each blister packed in a pouch along with one printed sleeve, one pack insert (with a day label), and one oxygen absorber sachet (Stabilox). Three pouches are then packed in one carton.
Pregnant Stacey Solomon brands herself an 'old fogy' over NYE plans with Joe
Taking the pills could result in unwanted pregnancies (Drugs.com)These recalled lots were distributed across the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets. The specific details of the recalled lots are as follows:
- Product: TydemyTM
- Lot No: L200183 / L201560
- Expiry: January 2024 / September 2024
- NDC(s): 68180-904-71 (1 Blister of 28 tablets each) / 68180-904-73 (3 Blister of 28 tablets each)
- UPC: 368180904731
- Distribution Dates: June 2022 to May 2023
Lupin said it is actively reaching out to wholesalers, distributors, drug chains, mail-order pharmacies, and supermarkets via phone and recall notifications. The company is coordinating the return of all the recalled product lots to address the issue promptly.
Patients who are currently taking Tydemy are advised to continue their medication but are also encouraged to contact their pharmacist, physician, or healthcare provider immediately for advice on alternative treatments. Wholesalers, distributors, and retailers who possess the recalled Tydemy lots are urged to stop the distribution of these products without delay.
For any questions or concerns related to the recall, consumers, wholesalers, distributors, and retailers can contact Inmar Rx Solutions, Inc. at (866) 480-8206, Monday to Friday, from 09:00 am to 05:00 pm EST. For reimbursement, consumers can return the recalled lots to Inmar Rx Solutions, Inc., with the lot number located on the side of the carton. If anyone has experienced any issues related to taking or using this drug product, they are advised to get in touch with their physician or healthcare provider.
Any adverse reactions or quality problems experienced with the use of this product can be reported to the FDA's MedWatch Adverse Event Reporting program online. To report by regular mail or by fax, download the form from the FDA's website or call 1-800-332-1088 to request a reporting form. Complete the form and return it to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178.