The Recall Desk
HighFDA (Drugs)·D-408-2014·Announced 2014-01-22

Lupin Recalls Quinapril Tablets Due to Unknown Impurity

Lupin Pharmaceuticals is recalling Quinapril tablets because an unknown impurity exceeded specification limits during stability testing.

What this means for you

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, and the hazard involves an unknown impurity exceeding specifications, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Quinapril Tablets USP, 5 mg, 90 count bottles. The recall affects 30,264 bottles distributed nationwide and in Puerto Rico. The specific lots involved are 3104879, 3104880 (Exp. 10/13), 3110218, 3110219, and 3110220 (Exp. 12/13).

The recall was initiated because an unknown impurity was found to be above the specification limit during stability testing at the 36-month test interval. This is a 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 with these specific lots of Quinapril tablets should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
QUINAPRIL (QUINAPRIL)
Brand
QUINAPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
30,264

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 (6)

  • Lots 3104879
  • 3104880
  • Exp. 10/13
  • 3110218
  • 3110219
  • 3110220 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 →

Related recalls

Same brand · QUINAPRIL

Same manufacturer · Lupin Pharmaceuticals Inc.

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Same hazard · impurity

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