Why it was recalled
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Product description
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
Lot numbers, UPCs & expiration codes
Lot: H801227, Exp. Date January 2020
Where it was sold
Nationwide within the United States
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-0638-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 26, 2019
- FDA report date
- Jan 15, 2020
- Quantity
- 41,863 cartons/3 wallets per carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0638-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84571
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot: H801227, Exp. Date January 2020
- Postal code
- 21202-6174
- Report date
- Jan 15, 2020
- Product type
- Drugs
- Recall number
- D-0638-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 41,863 cartons/3 wallets per carton
- Termination date
- Oct 22, 2020
- Reason for recall
- Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 3, 2020