D-0638-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2020
- Initiation Date
- December 26, 2019
- Termination Date
- October 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,863 cartons/3 wallets per carton
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
Reason for Recall
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Distribution Pattern
Nationwide within the United States
Code Information
Lot: H801227, Exp. Date January 2020