CARDINAL HEALTHCARE
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
Batch MY7E
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →