Recalls / Class III
Class IIID-0790-2020
Product
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
- Affected lot / code info
- Lot # L800498, exp. date February 2020
Why it was recalled
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
- Distribution pattern
- Distributed nationwide in the US
Timeline
- Recall initiated
- 2020-01-10
- FDA classified
- 2020-01-17
- Posted by FDA
- 2020-01-22
- Terminated
- 2021-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0790-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.