December 2018 FDA Recall Levoxyl by Pfizer Inc.
D-0339-2019 - Superpotent Drug.
This Class II drug recall was voluntarily initiated by Pfizer Inc. on December 6, 2018 for the product Levoxyl. The FDA reported the reason for recall as superpotent drug.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0339-2019
Superpotent Drug.
12-06-2018
12-26-2018
1996 bottles
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.
Pfizer Inc.
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 within the United States
10-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01
Batch or Lot Expiration Information
Lot# :18A18, Exp. 01/2020
