Class II · Moderate risk Terminated
Ethosuximide Oral Solution USP 250 mg/5 mL
Reason Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
ethosuximide capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
What was recalled
ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2
- Recalling firm
- Pfizer Inc.
- NDC code
- 59762-2250-2
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0001-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ethosuximide recalls
See all
Class III · Low risk Terminated
Zarontin
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.
Class II · Moderate risk Terminated
Ethosuximide Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
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