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.

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

Recall #: D-1667-2012
Affected scope: 963,407 bottles
Initiated: June 15, 2011

Compiled from official public sources by the publisher. · Updated September 2026

Apotex Corp. recalled Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), R… - a low-severity action.

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), R… was recalled by Apotex Corp. in September 5, 2012. Reason: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.. Check the official notice for the remedy. Verify recall #D-1667-2012 with the FDA Drug before acting.

The recall

Apotex Corp. issued this low-severity FDA Drug recall-CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product..

Low
severity level: Class III
classification: September 5, 2012
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1667-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-1667-2012
Date reported	September 5, 2012
Date initiated	June 15, 2011
Recalling firm	Apotex Corp.
Firm location	Weston, FL
Affected scope	963,407 bottles
Distribution	Nationwide and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-1667-2012) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

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.

Where was the recalled product distributed? ▼

Distribution: Nationwide and Puerto Rico.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

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Similar Children & Baby Products · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Drug, reported September 5, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026