Recalls / Class III
Class IIID-0002-2020
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
- Brand name
- Zarontin
- Generic name
- Ethosuximide
- Active ingredient
- Ethosuximide
- Route
- Oral
- NDC
- 0071-0237
- FDA application
- NDA012380
- Affected lot / code info
- Lot #3267079, 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.
- Manufacturer
- Parke-Davis Div of Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 7,686 100-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-0002-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.