Home / Recalls / Lupin Pharmaceuticals Inc. / D-1565-2019

D-1565-2019 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
August 7, 2019
Initiation Date
July 2, 2019
Termination Date
February 16, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12938 units

Product Description

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)

Reason for Recall

Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.

Distribution Pattern

Nationwide in the USA

Code Information

Lot L800050

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