The Recall Desk
LowFDA (Drugs)·D-0244-2015·Announced 2014-11-12

Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

Apotex Inc. is recalling Candesartan Cilexetil Tablets, 32 mg, because out-of-specification results were observed for specific impurities and total impurities.

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 agency classified this as an FDA Class III recall, 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

Apotex Inc. is recalling Candesartan Cilexetil Tablets, 32 mg, in 30-count and 90-count bottles. The recall involves 22,710 bottles distributed nationwide. The specific lots affected are KR3955 (Exp. 10/15), KV0430 (Exp. 11/15), and KT6063 (Exp. 10/15).

The recall was initiated because out-of-specification (OOS) results were observed for CAD-II, CAD-V, and Total Impurities. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers should check their medication bottles for the NDC numbers 60505-3621-3 or 60505-3621-9 and the lot numbers listed above. If the product matches these details, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Manufacturer
Apotex Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
22,710

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 (4)

  • Lot #: a) KR3955
  • Exp. 10/15
  • KV0430
  • Exp. 11/15 Lot #: b) KT6063

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Apotex 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 4 products in this recall →

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