Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium
Summary
The FDA issued a Class I for Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0 by Lupin Pharmaceuticals Inc.. Reason: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7.
Details
Source
Drug Recall
External ID
D-1081-2023
Action Date
2023-08-09
Status
Terminated
Category
drug
Product Description
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA
Lot/Code Info: Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
Quantity Affected: 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
Reason for Recall
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-23
Company
Baltimore, MD
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 171 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1081-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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