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Recall Observatory FDA recall evidence

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

June 15, 2011

Class III

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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations