Recalls / Class II
Class IID-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)
- Affected lot / code info
- Lot L800050
Why it was recalled
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 12938 units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-07-02
- FDA classified
- 2019-07-30
- Posted by FDA
- 2019-08-07
- Terminated
- 2021-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1565-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.