The Recall Desk
ModerateFDA (Drugs)·D-1324-2022·Announced 2022-08-17

Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage

Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The recall is due to a CGMP compliance deviation (improper storage) without documented safety incidents, qualifying it as a quality control matter rather than an active safety threat.

Plain-English summary

Asthmanefrin Racephinephrine Inhalation Solution, a bronchodilator for temporary relief of mild symptoms of intermittent asthma, is being recalled. The recall affects products distributed nationwide in the United States.

The product is being recalled due to a CGMP (good manufacturing practices) deviation: products were stored outside the conditions specified on the drug label. This storage deviation was identified by McKesson Medical-Surgical Inc., the recalling firm.

Consumers who have obtained this product should consult with their healthcare provider or pharmacist regarding whether continued use is appropriate.

The recalled product

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.
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug
Hazard
  • improper-storage
  • cgmp-deviation

Distribution

Distributed nationwide across the United States.