Recalls / Class III
Class IIID-0264-2022
Product
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.
- Affected lot / code info
- Lot #: L000784 and L000785, Exp. Date May 2022
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 4113 cartons
- Distribution pattern
- nationwide within the United States
Timeline
- Recall initiated
- 2021-11-19
- FDA classified
- 2021-12-01
- Posted by FDA
- 2021-12-08
- Terminated
- 2022-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0264-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.