Recall Enforment Report D-0002-2020

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Pfizer Inc., originally initiated on 09-12-2019 for 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 The product was recalled due to 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 product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0002-202009-12-201910-02-2019Class III7,686 100-count bottlesZarontin (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 0071-0237-24Labeling: 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.Terminated
D-0001-202009-12-201910-02-2019Class III7,824 100-count bottlesethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2Labeling: 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.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0071-0237Zarontin EthosuximideCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug