FDA-Drug2016-07-20Class II

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80

Pharmakon Pharmaceuticals, Inc.
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Affected count
142
Manufactured in
14450 Getz Rd, Noblesville, IN, United States
Products
Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1290-2016

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