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
- Company Announcement Date:
- August 17, 2017
- FDA Publish Date:
- February 06, 2018
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionLack 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 DescriptionAll compounded injectable prescription medications
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.