Class III
Terminated
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.
- Company
- Apotex Corp.
- Recall Initiated
- June 15, 2011
- Posted
- September 5, 2012
- Recall Number
- D-1667-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 963,407 bottles
- Firm Location
- Weston, FL, United States
Reason for Recall
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
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