Taro Pharmaceuticals Issues Voluntary Nationwide Product Recall of Lamotrigine Tablets Over Cross Contamination
As reported on FDA.gov: on January 10, 2020, Taro Pharmaceuticals U.S.A., Inc. issued a voluntary product recall of one lot of Lamotrigine 100 mg Tablets (Lot # 331771 with expiration date June 2021 in 100 count bottles, NDC 51672-4131-1 to the consumer level). The lot is being recalled because it was found to have been cross-contaminated with a small amount of another drug substance called Enalapril Maleate, that is used to manufacture another pharmaceutical at the same facility. Read the full press release here: https://www.businesswire.com/news/home/20200110005522/en/External Link Disclaimer
Product recall due to following risks to consumers
Enalapril Maleate is a drug substance used to treat hypertension and congestive heart failure but there are risks associated with the drug for those who don’t need it. Risks include:
- With long-term exposure to Enalapril Maleate, there could be serious health impacts to users, especially to pregnant women and small children.
- Enalapril Maleate is known to increase the risk of birth defects in a developing fetus.
According to Taro, the company has not received any Lamotrigine 100 mg Tablets product complaints or any reports of injuries related to the recall.
Taro is notifying its distributors and customers by phone, email, and letters. The manufacturer is asking retailers, pharmacies and distributors to stop distributing or dispensing this product and return it to Taro. Consumers with this product on hand should stop using it and return to the pharmacy that dispensed it to them.
Consumers who have questions about this recall can contact Taro at 1-866-923-4914 or TaroPVUS@taro.com, Monday through Friday between 7 a.m. and 7 p.m. US Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Call 1- 800-332-1088 to request a reporting form.
Defective product liability claims
When a product causes harm, a defective product liability claim may be appropriate. There are three common categories for defective product claims:
(1) Defective manufacture / manufacturer error;
(2) Defective / dangerous design; or
(3) Failure to provide adequate warnings or instructions for the proper use of the product.
A product is considered defectively manufactured when there was an error in making it, like an assembly line error or equipment error. The end result is an injury-causing product different from the other products on the shelf. In this case, one drug was cross-contaminated with another drug, making it unsafe to consume.
This type of product recall could turn into a defective product liability claim under the defective manufacture/manufacturer error category if it could be proved that the manufacturer was aware of the cross-contamination and sold the pills anyway.
In addition, your personal injury lawyer would need to prove that the injury was caused by the manufacturing defect, rather than a user error such as taking the wrong dosage despite an accurate prescription and instructions.
Seek the help of a prescription drug error attorney
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