Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium t
Summary
The FDA issued a Class III for Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.0 by Lupin Pharmaceuticals Inc.. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0264-2022
Action Date
2021-12-08
Status
Terminated
Category
drug
Product Description
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.
Lot/Code Info: Lot #: L000784 and L000785, Exp. Date May 2022
Quantity Affected: 4113 cartons
Reason for Recall
Subpotent Drug
Distribution
nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-19
Company
Baltimore, MD
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 18 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0264-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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