June 2017 FDA Recall Option 2 by L. Perrigo Company
D-0887-2017 - Defective Container
This Class II drug recall was voluntarily initiated by L. Perrigo Company on June 1, 2017 for the product Option 2. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0887-2017
Defective Container: Carton is missing the tablet blister strip and tablet.
06-01-2017
06-14-2017
181,776 (units/eaches)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
L. Perrigo Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US and Canada
11-21-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12
Batch or Lot Expiration Information
Lot# : 6LV1114, 6LV1115, 6LV1116, 6MV0976, 6MV0977, Exp.04/18; 7AV1173, 7AV1175, 7AV1176, Exp.07/18.
