Drug 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
D-0002-2020
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 83788
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,686 100-count bottles
- Official record key
drug-enforcement:D-0002-2020
Official wording
Reason: 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
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing