FDAFDA · Food and drugs·Recall number D-0148-2018
All Sterile Products within expiry
Published December 27, 2017 · Recall initiated: August 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility .
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
- Distributor
- Nationwide.
- Lot
- Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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