FDA Drug recall D-1667-2012
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Can…
- FDA Drug
- Class III
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class III recall of Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Can… by Apotex, citing CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1667-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-06-15 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
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
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Identifiers
| ndc | 60505-0833-5 |
|---|---|
| code_info | Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1667-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.