November 2021 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-0264-2022 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on November 19, 2021 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0264-2022

Reason for Recall
Subpotent Drug
Initiated
11-19-2021
Reported
12-08-2021
Quantity
4113 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89085
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.
nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-15-2022
Product Description About Product Description
Full technical description of the product.
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.

Batch or Lot Expiration Information

Lot# : L000784 and L000785, Exp. Date May 2022