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.
Reported: September 5, 2012 Initiated: June 15, 2011 #D-1667-2012
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.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 963,407 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Apotex Corp.. Units affected: 963,407 bottles.
Why was this product recalled? ▼
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2012. Severity: Low. Recall number: D-1667-2012.
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