Drug 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.
D-1667-2012
Product summary
- Firm
- Apotex Corp.
- Event
- Event 62930
- Status
- Terminated
- Classification
- Class III
- Quantity
- 963,407 bottles
- Official record key
drug-enforcement:D-1667-2012
Official wording
Reason: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Code information: Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations