Lupin Pharmaceuticals Inc. 2023-08-09 Health critical FDA
Health · FDA · Recall #FDA-D-1081-2023
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03… Recall
Issued August 9, 2023 · Lupin Pharmaceuticals Inc.
In August 2023, Lupin Pharmaceuticals Inc. recalled the Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
What you should do
- 1 Stop using Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Lupin Pharmaceuticals Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Lupin Pharmaceuticals Inc.
- Category
- Health
- Recall date
- August 9, 2023
- Units affected
- Not reported
- Sold at
- USA nationwide.
- Recall number
- FDA-D-1081-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Lupin Pharmaceuticals Inc. has 19 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.