Drug recall D-1667-2012
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.
Lots and codes
Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Recall details
- Recalling firm
- Apotex Corp., Weston, FL
- Quantity
- 963,407 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 15, 2011
- Terminated
- September 18, 2012
Related products
- Azelastine Hydrochloride – drug information
- NDC 60505-0833 Azelastine Hydrochloride · Azelastine Hydrochloride 137 ug/1 · Apotex Corp.