Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
(NDC 51672-4131-1) Lot # 331771 (Expiration
Due to Cross-Contamination With Enalapril Maleate
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Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. There is potential with chronic exposure to Enalapril Maleate to impact users particularly if they are small children or pregnant women. Enalapril Maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date
Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall. Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with
Lamotrigine 100 mg Tablets are indicated for Epilepsy and Bipolar disorder. This product is packaged in white plastic bottles with screw cap closure, and each bottle contains 100 tablets. Each bottle is labeled to indicate the name of the product, Lamotrigine Tablets USP, 100 mg, the NDC #51672-4131-1 (see image of container label below), the lot number 331771 and expiration date of
Lamotrigine 100 mg Tablets, Lot # 331771 were distributed to wholesale distributors in the US market
Taro is notifying its distributors and customers by Phone, E-mail, and Letters via US Mail and is arranging for return of any containers or quantities of Lamotrigine 100 mg Tablets, Lot # 331771 (exp.
Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 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
This recall is being conducted with the knowledge of the
About Taro
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 Company’s financial performance, availability of financial information, and estimates of financial results and information for fiscal year 2020. 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. Factors that could cause actual results to differ include general domestic and international economic conditions, industry and market conditions, changes in the Company's financial position, litigation brought by any party in any court in
View source version on businesswire.com: https://www.businesswire.com/news/home/20200110005522/en/
Source:
COMPANY / INVESTORS:
William J. Coote
AVP, Treasurer – Interim CFO
(914) 345-9001
William.Coote@taro.com
CONSUMERS:
Taro Pharmaceuticals U.S.A., Medical Information
1-866-923-4914
TaroPVUS@taro.com