PlainRecalls
FDA Drug Moderate Class II Terminated

Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

Reported: June 17, 2015 Initiated: May 15, 2015 #D-1120-2015

Product Description

Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

Reason for Recall

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Details

Units Affected
1/5mL vial
Distribution
MT and ND
Location
Missoula, MT

Frequently Asked Questions

What product was recalled?
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.. Recalled by Montana Compounding Pharmacy. Units affected: 1/5mL vial.
Why was this product recalled?
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Which agency issued this recall?
This recall was issued by the FDA Drug on June 17, 2015. Severity: Moderate. Recall number: D-1120-2015.