Drug product
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
D-0638-2020
Product summary
- Event
- Event 84571
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41,863 cartons/3 wallets per carton
- Official record key
drug-enforcement:D-0638-2020
Official wording
Reason: Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Code information: Lot: H801227, Exp. Date January 2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.