September 2014 FDA Recall Losartan Potassium by Micro Labs Usa, Inc S
D-0253-2015 - Failed Content Uniformity Specifications; Dry mix failed blend uniformity.

This Class II drug recall was voluntarily initiated by Micro Labs Usa, Inc S on September 22, 2014 for the product Losartan Potassium. The FDA reported the reason for recall as failed content uniformity specifications; dry mix failed blend uniformity.. The product was distributed in U.S. Including: New York and the recall is currently terminated.

Recall Number: D-0253-2015

Reason for Recall
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Initiated
09-22-2014
Reported
11-26-2014
Quantity
144 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69590
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Micro Labs Usa, Inc S
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: New York
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-22-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# LJAG003, Expiry: 05/2015

Affected Packages Involved in this Recall

42571-110-30 Losartan Potassium
42571-110-90 Losartan Potassium
42571-110-10 Losartan Potassium
42571-111-30 Losartan Potassium
42571-111-90 Losartan Potassium
42571-111-10 Losartan Potassium
42571-112-30 Losartan Potassium
42571-112-90 Losartan Potassium
42571-112-10 Losartan Potassium