Recalls / Class II
Class IID-1172-2022
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
- Affected lot / code info
- Lot #: 379073, 379079, Exp 9/30/2023
Why it was recalled
Defective container: defect prevents product from dispensing as intended.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 44,400 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-06-13
- FDA classified
- 2022-06-30
- Posted by FDA
- 2022-07-06
- Terminated
- 2024-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1172-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.