Drug 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)
D-0790-2020
Product summary
- Event
- Event 84674
- Status
- Terminated
- Classification
- Class III
- Quantity
- 34,080 boxes (3 wallets per carton, 80 cartons per box)
- Official record key
drug-enforcement:D-0790-2020
Official wording
Reason: CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Code information: Lot # L800498, exp. date February 2020
Distribution pattern: Distributed nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Out of specification