The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-409-2014·Announced 2014-01-22

Lupin Recalls Quinapril Tablets Due to Unknown Impurity Exceeding Limits

Lupin Pharmaceuticals is recalling Quinapril 10 mg tablets because stability testing revealed an unknown impurity above specification limits.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific reports of hospitalization or serious injury fall into the High severity category, representing a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Quinapril Tablets USP, 10 mg, 90 count bottles (NDC 68180-557-09). The recall involves 22,896 bottles distributed nationwide and in Puerto Rico. The specific lot affected is 3110358 with an expiration date of 12/13.

The recall was initiated because stability testing identified an unknown impurity that exceeded the specification limit at the 36-month test interval. This is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this specific lot of Quinapril should stop using it and contact their healthcare provider or pharmacist for guidance. The product is a prescription medication, so patients should not discontinue treatment without consulting a medical professional.

The recalled product

Product
QUINAPRIL (QUINAPRIL)
Brand
QUINAPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard

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 3110358 Exp. 12/13

UPCs (2)

  • 0368180559092
  • 0368180556091

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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