D-0790-2020 Class III Terminated
FDA drug recall D-0790-2020 was initiated by Lupin Pharmaceuticals Inc. on January 10, 2020 and is designated Class III. Reason for recall: CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. The recall status is terminated (terminated June 3, 2021). Affected quantity: 34,080 boxes (3 wallets per carton, 80 cartons per box).
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2020
- Initiation Date
- January 10, 2020
- Termination Date
- June 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
Product Description
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)
Reason for Recall
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Distribution Pattern
Distributed nationwide in the US
Code Information
Lot # L800498, exp. date February 2020