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Recall Observatory FDA recall evidence

Drug product

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16

D-1172-2022

June 13, 2022

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 90405
Status
Terminated
Classification
Class II
Quantity
44,400 bottles
Official record key
drug-enforcement:D-1172-2022

Official wording

Reason: Defective container: defect prevents product from dispensing as intended.

Code information: Lot #: 379073, 379079, Exp 9/30/2023

Distribution pattern: Nationwide USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container: defect prevents product from dispensing as intended.