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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83788

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 12, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Pfizer Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2

D-0001-2020
Recall number
D-0001-2020
Initiated
September 12, 2019
Classification
Class III
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
7,824 100-count bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot #3267079A, Exp 09/2021

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

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

D-0002-2020
Recall number
D-0002-2020
Initiated
September 12, 2019
Classification
Class III
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
7,686 100-count bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot #3267079, Exp 09/2021

Distribution pattern

Nationwide in the USA