The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0401-2015·Announced 2015-03-11

AvKARE Recalls Subpotent Quinapril Tablets Due to Low Dosage

AvKARE Inc. is voluntarily recalling 214 unit dose packs of Quinapril 5 mg tablets nationwide because the medication is subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

AvKARE Inc. has voluntarily initiated a recall of 214 unit dose packs of Quinapril Tablets USP, 5 mg. The affected product is identified by Lot number I1404952 and an expiration date of 02/2016. The recall was initiated on February 27, 2015, and the product was distributed nationwide.

The reason for the recall is that the medication is subpotent, meaning it does not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP). The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected Quinapril tablets and contact their pharmacist or physician for a replacement prescription. The recall was terminated on September 22, 2015.

The recalled product

Product
Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
214

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 number: I1404952
  • Exp. 02/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE 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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