May 2017 FDA Recall Drug by Lupin Limited (unit 1) (D-1093-2017 - Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.)

This Class I drug recall was voluntarily initiated by Lupin Limited (unit 1) on May 16, 2017 for the product Drug. The FDA reported the reason for recall as contraceptive tablets out of sequence- first 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1093-2017

Reason for Recall
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Initiated
05-16-2017
Reported
08-23-2017
Quantity
24,652 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77323
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 Limited (Unit 1)
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-30-2019
Product Description About Product Description
Full technical description of the product.
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202

Batch or Lot Expiration Information

Batch# Batch Number L600518; Exp. 05/18