FDAFDA · Food and drugs·Recall number D-1667-2012
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.
Published September 5, 2012 · Recall initiated: June 15, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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