After the FDA found traces of an unexpected impurity known as NMBA in batches of multiple blood pressure medications, Torrent Pharmaceuticals Limited has further expanded its recall of the medications. This will make the fifth such expansion on the recall.
Use of the Affected Medications
The Losartan medications that are part of the recall are typically prescribed to patients with Type 2 diabetes for treatment of left ventricular hypertrophy and nephropathy, as well as hypertension. The Losartan Potassium and Hydrochlorothiazide tablets, USP are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
Medications Affected by the Recall
The affected medications include Losartan Potassium Tablets USP and Losartan Potassium/Hydrochlorothiazide tablets. The specific medications that were recalled include:
- Losartan Potassium Tablets, USP 50 mg, 1,000 count
- Losartan Potassium Tablets, USP 100 mg, 90 count
- Losartan Potassium Tablets, USP 100 mg, 1,000 count
- Losartan Potassium/Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg, 90 count
- Losartan Potassium/Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count
The recall is limited to lots of the medications that contain NMBA above the acceptable daily intake level approved by the FDA.
Manufacturer’s Response
The manufacturer is currently notifying distributors and customers via phone and mail about the recall. It is advising them to stop distribution of the lots that are involved in the recall and asking them to notify their own customers. Instructions for returning the medication are included in the recall letter.
Consumer Action
The FDA is urging patients who were prescribed this mediation to contact their physician or pharmacist to receive alternative treatment and not to discontinue taking their medication until an alternative is prescribed.
Consumers who have medical questions or want to report an adverse event to the company can contact Torrent Pharmaceuticals Limited. Consumers who have experienced a health issue related to taking the medication should contact their physician or healthcare provider.
Adverse reactions can also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mailing in the form or by faxing it to 1-800-FDA-0178.
