Why it was recalled
CGMP Deviations: products were stored outside the drug label specifications.
Product description
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.
Lot numbers, UPCs & expiration codes
No codes were listed in the FDA report.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1324-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 1 box
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
Original FDA data
Every field from FDA enforcement report D-1324-2022, exactly as published.
Show all FDA fields
- City
- Richmond
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 90553
- Address
- 9954 Maryland Drive
- Address (line 2)
- Deep Run Iii Ste. 4000
- Postal code
- 23233
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1324-2022
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product quantity
- 1 box
- Termination date
- Feb 13, 2024
- Reason for recall
- CGMP Deviations: products were stored outside the drug label specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2022