FDA MedWatch - Two Lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets) by Lupin Pharmaceuticals

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TOPIC: Two Lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) by Lupin Pharmaceuticals: Recall - Due to Out of Specification Results at the 12-month Stability Time Point

AUDIENCE: Consumer, Patient, Health Professional, Endocrinology, OBGYN, Pharmacy

ISSUE: Lupin Pharmaceuticals is 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) due to out of specification 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. The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.

To date, Lupin has received no reports of adverse events related to either recalled batches.

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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Tydemy is estrogen/progestin oral contraceptive indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception.

RECOMMENDATIONS: 

• 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.

• 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.

• Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact the company.

• Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately.

Patients and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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