Why it was recalled
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Product description
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
Lot numbers, UPCs & expiration codes
Lot # L800498, exp. date February 2020
Where it was sold
Distributed nationwide in the US
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-0790-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 10, 2020
- FDA report date
- Jan 22, 2020
- Quantity
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0790-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84674
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # L800498, exp. date February 2020
- Postal code
- 21202-6174
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0790-2020
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
- Termination date
- Jun 3, 2021
- Reason for recall
- CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
- Distribution pattern
- Distributed nationwide in the US
- Recall initiation date
- Jan 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2020