A recall of the popular birth control, Tydemy, has been issued by Lupin Pharmaceuticals, Inc. and the FDA after poor stability testing results. The manufacturer noted that after 1 year, there was a significant decline in ascorbic acid, leading to a reduction in effectiveness. As of the writing of this notice, no adverse effects have been reported. Unexpected pregnancies may have occurred, however.
SUMMARY
Date of Recall:
Announced: July 29, 2023
Public Notification: July 31, 2023
Name(s) of Drug:
Tydemy™
Drospirenone, Ethinyl Estradiol and Levomefolate Calcium, 3mg/0.03mg/0.451mg
Levomefolate Calcium 0.451mg
Company Name:
Lupin Pharmaceuticals, Inc.
Drug Indication:
Pregnancy Prevention
Product Description
Tydemy is packaged in blister packs within a printed sleeve. The sleeve is orange and blue in color and bears the name Tydemy™ as well as lot information.
Reason for Recall
Decreased effectiveness caused by the instability of the ingredients may lead to unexpected pregnancies.
Impacts
Consumers who continue to utilize this contraceptive may experience unexpected pregnancies during its use.
Lot Information
Consumers should locate the package in which the medication comes to compare NDC, UPC, and lot numbers, as well as expiration dates, with the chart below. If you find your NDC number, UPC lot number, and expiration date on the chart below, your medication is affected by the recall. You will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.
Product Description |
Lot Number |
Expiration Date |
NDC |
UPC |
Distribution Dates |
| Tydemy™ | L200183 |
01/2024 |
68180-904-71 (1 Blister of 28 Tablets)
68180-904-73 (3 Blisters of 28 Tablets) |
368180904731 |
06/2022-05/2023 |
| L201560 |
09/2024 |
Have you found that your birth control medication is part of the recall? Here’s what you should do:
Consumers
NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY. SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.
Sudden discontinuation of this medication may cause side effects. These may include:
- Weight changes
- Acne
- Changes in Menstrual Cycle
- Changes in Mood
- Changes in Sex Drive
- Unexpected Pregnancy
If you find that your lot of medication is part of this recall, do the following:
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any unexpected symptoms.
- Monitor your health for signs of pregnancy and notify your physician if you think you may be pregnant.
- Consumers should contact Inmar Rx Solutions at 1-866-480-8206. They are available Mon-Fri from 9:00am to 5:00pm (EST). If necessary, reimbursement can be provided.
- If you are currently experiencing or have experienced an adverse reaction to this medication, notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact Inmar Rx Solutions at 1-866-480-8206. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact Inmar Rx Solutions at 1-866-480-8206. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!