FDA Drug Recalls

Recalls / Class III

Class IIID-0001-2020

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

Affected lot / code info
Lot #3267079A, Exp 09/2021

Why it was recalled

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.

Recalling firm

Firm
Pfizer Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
235 E 42nd St, New York, New York 10017-5703

Distribution

Quantity
7,824 100-count bottles
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2019-09-12
FDA classified
2019-10-01
Posted by FDA
2019-10-02
Terminated
2023-04-10
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0001-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.