The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0253-2015·Announced 2014-11-26

Micro Labs Recalls Losartan Potassium Tablets for Content Uniformity Failures

Micro Labs USA is recalling 1,440 bottles of Losartan Potassium 25 mg tablets because the dry mix failed blend uniformity specifications.

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 FDA classifies this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it indicates a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Micro Labs USA, Inc. is recalling 1,440 bottles of Losartan Potassium Tablets USP, 25 mg, 1000 Tablet Bottles. The product is identified by NDC 42571-110-10, Lot #LJAG003, and an expiration date of 05/2015. The recall was initiated because the dry mix failed blend uniformity specifications, resulting in a failure of Content Uniformity Specifications.

The affected product was distributed in the United States, including New York. The tablets were manufactured by Micro Labs Limited in Goa, India, for Micro Labs USA, Inc. in Princeton, New Jersey.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
Manufacturer
Micro Labs Usa, Inc S
Category
Drug — Prescription Medication
Hazard
Affected units
144

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 (2)

  • Lot #LJAG003
  • Expiry: 05/2015

Distribution

Distributed in 1 state:

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