FDA recall D-1565-2019

Product

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-07-02

Report date

2019-08-07

Termination date

2021-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1565-2019