The Recall Desk
SevereFDA (Drugs)·D-0018-2021·Announced 2020-10-14

Direct Rx Recalls Losartan Potassium 100 mg Tablets Due to Impurity

Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets found to contain an impurity above acceptable levels.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the presence of a nitrosamine impurity.

Plain-English summary

Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets, 30-count bottles, prescription only. The product is identified by NDC 61919-952-30, Lot 27AU1801, and an expiration date of 02/28/2021.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake.

The affected product was distributed in Georgia. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.

The recalled product

Product
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
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: 27AU1801 Exp. 02/28/2021

Distribution

Distributed in 1 state:

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