FDA recall D-0001-2020

Pfizer Inc. · Class III · drug

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

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

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-09-12
Report date
2019-10-02
Termination date
2023-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2020