Azelastine HCl Nasal Solution recall: CGMP Deviations
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…
Why was Azelastine HCl Nasal Solution recalled?
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
- Product
- 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…
- Recalling firm
- Apotex Corp.
- Quantity
- 963,407 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- September 5, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)