AvKARE Recalls Subpotent Quinapril Tablets Due to Low Drug Content
AvKARE Inc. is voluntarily recalling 431 unit dose packs of Quinapril Tablets USP, 40 mg, because the medication was found to be subpotent.
What this means for you
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. is voluntarily recalling 431 unit dose packs of Quinapril Tablets USP, 40 mg, Rx only. The recall was initiated on February 27, 2015, and the product was distributed nationwide. The specific lot number is I1407932, with an expiration date of 02/2016.
The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient as labeled. The FDA 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 healthcare provider for a replacement prescription. The recall was terminated on September 22, 2015.
The recalled product
- Product
- Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 431
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: I1407932
- 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.
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