PlainRecalls
FDA Drug Moderate Class II Terminated

Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70

Reported: July 20, 2016 Initiated: April 20, 2016 #D-1333-2016

Product Description

Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
1925
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Location
Noblesville, IN

Frequently Asked Questions

What product was recalled?
Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70. Recalled by Pharmakon Pharmaceuticals, Inc.. Units affected: 1925.
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-1333-2016.