Multi-event September 2019 FDA Recall Zarontin by Pfizer Inc.

This Multi-event Class III drug recall was voluntarily initiated by Pfizer Inc. on September 12, 2019 for the product Zarontin. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0001-2020 TERMINATED D-0002-2020 TERMINATED

Recall Number: D-0001-2020

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Initiated
09-12-2019
Reported
10-02-2019
Quantity
7,824 100-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83788
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.
Pfizer 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 in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2023
Product Description About Product Description
Full technical description of the product.
ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2

Batch or Lot Expiration Information

Lot# 3267079A, Exp 09/2021

Recall Number: D-0002-2020

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Initiated
09-12-2019
Reported
10-02-2019
Quantity
7,686 100-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83788
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.
Pfizer 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 in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2023
Product Description About Product Description
Full technical description of the product.
Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24

Batch or Lot Expiration Information

Lot# 3267079, Exp 09/2021

Affected Packages Involved in this Recall

0071-0237-24 Zarontin