Recalls / Class II
Class IID-1324-2022
Product
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
Why it was recalled
CGMP Deviations: products were stored outside the drug label specifications.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 1 box
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2024-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1324-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.