The Recall Desk
SevereFDA (Drugs)·D-1500-2014·Announced 2014-08-06

Jubilant Cadista Recalls Losartan Potassium and Hydrochlorothiazide Tablets

Jubilant Cadista Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide tablets due to the presence of stainless steel blemishes.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage are rated as Severe (4). The presence of stainless steel in tablets poses a risk of injury.

Plain-English summary

Jubilant Cadista Pharmaceuticals Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle. The recall involves 9,358 bottles of the medication, identified by Lot #14P0292 with an expiration date of 04/2016. The product was distributed nationwide and in Puerto Rico.

The recall was initiated because the tablets may contain dark blemishes identified as stainless steel. This is a Class II recall, indicating a situation in which there is a reasonable probability that the 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.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recalled product is a prescription medication, so patients should consult their prescriber before discontinuing or changing their treatment regimen.

The recalled product

Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Brand
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Affected units
9,358

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 #14P0292
  • Exp 04/2016

UPCs (3)

  • 0359746338107
  • 0359746337100
  • 0359746339104

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: