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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #3267079, Exp 09/2021
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0002-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 12, 2019
- FDA report date
- Oct 2, 2019
- Quantity
- 7,686 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0002-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83788
- Address
- 235 E 42nd St
- Code information
- Lot #3267079, Exp 09/2021
- Postal code
- 10017-5703
- Report date
- Oct 2, 2019
- Product type
- Drugs
- Recall number
- D-0002-2020
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 7,686 100-count bottles
- Termination date
- Apr 10, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2019