Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Fluticasone Propionate Nasal Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.
Affected NDC
50383-0700-16
Compare with the code on your package — it is the most precise check available.
Drug: Fluticasone Category: Allergy & Cold Medication
- Recalling firm
- Akorn, Inc.
- NDC code
- 50383-700-16
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0405-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluticasone recalls
See all
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by Akorn, Inc.
All 2015 recalls
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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