Food, drugs, devices › Viatris Inc
Drug recall: alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 0797
FDA enforcement event 90045 is a drug recall by Viatris Inc of Canonsburg, PA, initiated 28 Apr 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 21 Jun 2023. Initiation: voluntary: firm initiated. Viatris Inc has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Viatris Inc, Canonsburg, PA.
Reason for recall
"Failed Dissolution Specifications: low out-of-specification dissolution test results observed."
Distribution
"Product was distributed nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0844-2022 | alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1. | 6,789 bottles | Class II | Terminated | 11 May 2022 |
Context
Other enforcement events for Viatris Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Specifications: low out-of-specification dissolution test results observed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jun 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.