January 2020 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-0790-2020 - CGMP Deviations

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 10, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0790-2020

Reason for Recall
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Initiated
01-10-2020
Reported
01-22-2020
Quantity
34,080 boxes (3 wallets per carton, 80 cartons per box)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84674
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-03-2021
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# L800498, exp. date February 2020