D-0002-2020 Class III Terminated

Recalled by Pfizer Inc. — New York, NY

FDA drug recall D-0002-2020 was initiated by Pfizer Inc. on September 12, 2019 and is designated Class III. 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. The recall status is terminated (terminated April 10, 2023). Affected quantity: 7,686 100-count bottles.

Recall Details

Product Type
Drugs
Report Date
October 2, 2019
Initiation Date
September 12, 2019
Termination Date
April 10, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,686 100-count bottles

Product Description

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

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #3267079, Exp 09/2021