CLASS III Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
Azelastine HCl Nasal Solution, 1 %, 137 mcg/spray bottle recalled
Apotex is recalling Azelastine HCl Nasal Solution, 1 %, 137 mcg/spray bottle (200 Metered Sprays), distributed nationwide in the US. The recall was initiated on 15 Jun 2011 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1667-2012
- FDA event ID
- 62930
- Recalling firm
- Apotex, Weston, FL
- Manufacturer
- Apotex Corp.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Jun 2011
- FDA classified
- 29 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Nasal Sprays
Timeline
| 15 Jun 2011 | Recall initiated by company | |
| 29 Aug 2012 | Classified by FDA | +441 days |
| 5 Sep 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Azelastine HCl Nasal Solution, 1 %, 137 mcg/spray bottle (200 Metered Sprays) recalled?
Yes. Apotex recalled Azelastine HCl Nasal Solution, 1 %, 137 mcg/spray bottle (200 Metered Sprays) on 15 Jun 2011. The recall is Class III and its status is Terminated. Recall number D-1667-2012.
Why was it recalled?
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Which lots are affected?
Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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