Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Reported: June 17, 2015 Initiated: May 15, 2015 #D-1117-2015
Product Description
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 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
- Recalling Firm
- Montana Compounding Pharmacy
- Units Affected
- 1/5mL vial
- Distribution
- MT and ND
- Location
- Missoula, MT
Frequently Asked Questions
What product was recalled? ▼
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, 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-1117-2015.
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