D-0162-2024 Class II Terminated
FDA drug recall D-0162-2024 was initiated by CARDINAL HEALTHCARE on Jan 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. The recall status is terminated (terminated Sep 29, 2024). Affected quantity: 2 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 3, 2024
- Initiation Date
- Jan 26, 2022
- Termination Date
- Sep 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 cartons
Product Description
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
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution Pattern
Nationwide USA
Code Information
Batch MY7E
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0162-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026