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

FDA recall notice · announced January 15, 2020 · Lupin Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot: H801227, Exp. Date January 2020
Quantity: 41,863 cartons/3 wallets per carton
Status: Terminated
Products in this recall event:
- 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: (D-0638-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.