Reported Dec 8, 2021 · Terminated
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- 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 byLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated
- Manufactured byLupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13
- Lot codes and dates
Lot #: L000784 and L000785Exp. Date May 2022
- Amount recalled
- 4113 cartons
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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