Azelastine HCl Nasal Solution — Class III drug recall D-1667-2012
Terminated recall by Apotex Corp., reported 2012-09-05, distributed nationwide. CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
| Recall number | D-1667-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2011-06-15 |
| Classified | 2012-08-29 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 963,407 bottles |
| Reason classes | cgmp |
| NDC | 60505-0833, 60505-0833-05 |
| Lot numbers | 05/12, 07/12, 08/12, 12/12, JK9130, JM0925, JN1125, JN1127, JN6514, JR5780, JR5782 |
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 1T9, NDC 60505-0833-5.
Reason for recall
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1667-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.