Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Di
Summary
The FDA issued a Class II for Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, by Viatris Inc. Reason: Failed Dissolution Specifications: low out of specification results for dissolution..
Details
Source
Drug Recall
External ID
D-0854-2022
Action Date
2022-05-18
Status
Terminated
Category
drug
Product Description
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
Lot/Code Info: Lot #: DX7983, exp. date 02/28/2023
Quantity Affected: 110 bottles
Reason for Recall
Failed Dissolution Specifications: low out of specification results for dissolution.
Distribution
Product was distributed nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-28
Company
Canonsburg, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Viatris Inc has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Viatris Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Viatris Inc have FDA actions?
Viatris Inc has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0854-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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