Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC
Summary
The FDA issued a Class II for Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed B by Direct Rx. Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer..
Details
Source
Drug Recall
External ID
D-0507-2023
Action Date
2023-04-12
Status
Ongoing
Category
drug
Product Description
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Lot/Code Info: Lot: 11AP2219 Exp. 4/30/23
Quantity Affected: 20 bottles
Reason for Recall
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-22
Company
Dawsonville, GA
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 70 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Direct Rx has 30 FDA actions in our database, including 30 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 (Direct Rx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Direct Rx have FDA actions?
Direct Rx has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0507-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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