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Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, ...

FDA Recall #D-1667-2012 — Class III — June 15, 2011

Recall #D-1667-2012 Date: June 15, 2011 Classification: Class III Status: Terminated

Product Description

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

Reason for Recall

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

Recalling Firm

Apotex Corp. — Weston, FL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

963,407 bottles

Distribution

Nationwide and Puerto Rico

Code Information

Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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