PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 15, 2020 Initiated: December 26, 2019 #D-0638-2020

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.

Details

Units Affected
41,863 cartons/3 wallets per carton
Distribution
Nationwide within the United States
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 41,863 cartons/3 wallets per carton.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 15, 2020. Severity: Moderate. Recall number: D-0638-2020.