Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5 mL Due to Possible Underdosing or Overdosing
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The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening status epilepticus requiring immediate emergency room treatment. To date, Taro has not received any adverse event reports related to this recall.
The two (2) lots that are being recalled are as follows:
Lot #: |
Expiration Date: |
|
327874 |
December 2020 |
|
327876 |
December 2020 |
Each bottle is labeled to indicate the name of the product, Phenytoin Oral Suspension USP, 125 mg/5 mL and the NDC #51672-4069-1 (see image of container label below).
Lot 327874 was distributed to wholesale distributors, long-term care providers, a repackager and mail order customers in the U.S. market
Taro is notifying its distributors and retail customers by phone, e-mail, and letters via U.S. Mail and is arranging for return of any containers or quantities of Phenytoin Oral Suspension Lots # 327874 and 327876 (both with an expiration date of
Consumers with questions regarding this recall can contact Taro by calling 1-855-536-6300 or by e-mail at TaroPVUS@taro.com, Monday through Friday
Adverse reactions or quality problems experienced with the use of this product may be reported to the
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-
FDA -0178
SAFE HARBOR STATEMENT
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements that do not describe historical facts or that refer or relate to events or circumstances the Company “estimates,” “believes,” or “expects” to happen or similar language, and statements with respect to the voluntary recall of Phenytoin Oral Suspension USP, 125 mg/5 mL. Although the Company believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurances that its expectations will be attained. Further updates will be detailed from time to time in the Company’s
View source version on businesswire.com: https://www.businesswire.com/news/home/20200220005975/en/
Source:
COMPANY / INVESTORS:
William J. Coote
AVP, Treasurer – Interim CFO
(914) 345-9001
William.Coote@taro.com
CONSUMER:
Taro Pharmaceuticals U.S.A., Medical Information
1-855-536-6300
TaroPVUS@taro.com