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  4. Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Lack of Sterility Assurance
Company Name:
Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding
Brand Name:
Brand Name(s)
Atlantic Pharmacy and Compounding
Product Description:
Product Description
All compounded injectable prescription medications

Company Announcement

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy. 
 
Risk Statement: The compounded injectable prescription medications potentially could result in adverse effects.  To date, Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding has not received any reports of adverse events related to this recall.

The compounded injectable prescription is packaged in sterile vials for injection.

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is notifying its patients by U.S. Mail and is requesting that all unexpired lots of compounded injectable prescription medications be destroyed immediately upon receipt of the notification. Patients that have compounded injectable prescription medications which are being recalled should stop using the compounded injectable prescription medications and discard any remaining unused medication.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


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