Class II
Terminated
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)
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- July 2, 2019
- Posted
- August 7, 2019
- Recall Number
- D-1565-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12938 units
- Firm Location
- Baltimore, MD, United States
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
Lot / Code Info
Lot L800050
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