PlainRecalls
FDA Drug Moderate Class II Terminated

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Reported: June 17, 2015 Initiated: May 15, 2015 #D-1127-2015

Product Description

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Reason for Recall

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

Details

Units Affected
2/5 mL vials
Distribution
MT and ND
Location
Missoula, MT

Frequently Asked Questions

What product was recalled?
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT. Recalled by Montana Compounding Pharmacy. Units affected: 2/5 mL vials.
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-1127-2015.