AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Reported: February 3, 2016 Initiated: September 18, 2015 #D-0638-2016
Product Description
AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Reason for Recall
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Details
- Recalling Firm
- Sentara Enterprises
- Units Affected
- 12 Bags
- Distribution
- U.S. Including: VA, NC
- Location
- Chesapeake, VA
Frequently Asked Questions
What product was recalled? ▼
AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.. Recalled by Sentara Enterprises. Units affected: 12 Bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 3, 2016. Severity: Moderate. Recall number: D-0638-2016.
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