D-0844-2022 Class II Terminated
FDA drug recall D-0844-2022 was initiated by Viatris Inc on Apr 28, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications: low out-of-specification dissolution test results observed. The recall status is terminated (terminated Jun 21, 2023). Affected quantity: 6,789 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- Apr 28, 2022
- Termination Date
- Jun 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,789 bottles
Product Description
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
Reason for Recall
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Distribution Pattern
Product was distributed nationwide in the USA
Code Information
Lot # EH8348, exp. date August 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0844-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026