The FDA announced on 2011-06-15 that Apotex Corp. is recalling Azelastine HCl Nasal Solution due to CGMP deviations where filling tubing may interact with the formulation. The agency classified this as a Class III voluntary recall affecting 963,407 bottles distributed nationwide and in Puerto Rico.
How to tell if you have it
- Brand: Apotex
- Product: Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays)
- NDC: 60505-0833-5
- Lot codes: JK9130 (Exp 05/12), JM0925 (Exp 05/12), JN6514 (Exp 07/12), JN1125 (Exp 08/12), JN1127 (Exp 08/12), JR5780 (Exp 12/12), JR5782 (Exp 12/12)
- Quantity: 963,407 bottles
The hazard
The recall addresses CGMP deviations where the tubing used for filling may interact with the nasal formulation of the product. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Apotex Corp. has 24 other recalls on record since 2007-06-14. Recent brand-specific actions include an Apotex Paroxetine 37.5mg recall on 2026-09-23 due to dissolution failure and a Paxil CR 37.5mg Tablets recall on 2026-08-13 for failed stability testing. Other recent recalls of similar products include an Ajanta Pharma Fenofibrate Capsules Recall on 2026-05-28 and Wells Pharma Fentanyl Citrate Injectable Solution Recalls on 2026-04-01.