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.
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 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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