Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
Reported: July 20, 2016 Initiated: April 20, 2016 #D-1343-2016
Product Description
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Pharmakon Pharmaceuticals, Inc.
- Units Affected
- 70
- Distribution
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
- Location
- Noblesville, IN
Frequently Asked Questions
What product was recalled? ▼
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03. Recalled by Pharmakon Pharmaceuticals, Inc.. Units affected: 70.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 20, 2016. Severity: Moderate. Recall number: D-1343-2016.
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