D-0638-2020 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

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