Why it was recalled
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
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 numbers, UPCs & expiration codes
Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1081-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 23, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1081-2023, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 92588
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
- Postal code
- 21202-6174
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-1081-2023
- Classification
- Class I
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
- Termination date
- Jan 28, 2025
- Reason for recall
- Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Jun 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2023