The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0032-2021·Announced 2020-10-07

Losartan Pot/HCTZ 50/12.5 mg Recalled Due to Impurity Detection

Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets distributed in Florida due to trace amounts of impurity NMBA.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury reports or structural defects are Severe; while no injuries are explicitly reported, the presence of a nitrosamine impurity in a Class II drug recall aligns with the higher severity tier for significant potential harm.

Plain-English summary

Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets, 90-count, packaged and distributed by Direct Rx in Dawsonville, GA, and manufactured for Torrent Pharma, Inc. in Basking Ridge, NJ. The specific lot number is 12DE1806 with an expiration date of 01/31/2021. The product was distributed in Florida.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation where trace amounts of the impurity N-Methylnitrosobutyric acid (NMBA) were detected in the active pharmaceutical ingredient (API).

Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Manufacturer
Direct Rx
Category
Drug — Prescription Medication
Hazard
Affected units
33

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 12DE1806 Exp. 01/31/2021

Distribution

Distributed in 1 state:

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