Sun Pharmaceuticals recalled one of its products because the FDA laboratory’s testing failed. Recalled were over 34,000 bottles of generic diltiazem hydrochloride in a 360 mg dosage form.
The FDA enforcement report states the drug failed the stability and dissolution tests. The said medication is often used to treat high blood pressure and angina. It is also used for some types of irregular heartbeats.
The recall includes the following:
- Lot # HAC3120A: 6912 Bottles
- Lot # HAC3121A: 6792 Bottles
- Lot # HAC4460A: 6816 Bottles
- Lot # HAD0365A: 6744 Bottles
- Lot # HAD1452A: 6840 Bottles
Reports say Sun Pharma’s facility in Halol. India produced the recalled products. The company distributed the recalled drugs throughout the United States. These products come with expiry dates ranging from April 2023 to February 2024.
Sun Pharmaceuticals started the recall on January 13, 2023. But the agency classified it as a Class 2 recall earlier in February. A Class 2 recall covers situations that may cause temporary health consequences. It may also cause a remote chance of serious health outcomes.
Sun Pharma’s facility in Halol is facing some serious scrutiny from US regulators. In December 2022, FDA gave an import alert to the Halol facility. This means the agency had enough evidence to detain products without examination. Moreover, the agency can refuse entry of the items into the US market. That is until the facility corrects the issues and becomes compliant with cGMP.
What To Do
Authorities warned people who may be in possession of the drug to immediately stop using it. If possible, they should return the product to where they bought it.
You may contact the Office of the Director of the Chemistry, Food, and Drugs Division. Call them at 623-5242 or email them at cfdd@health.gov.tt. The Ministry of Health assures that it will continue to keep watch of the situation.