Class II · Moderate risk
Alprostadil Container Description: Amber color bottle
CGMP Deviations
Alprostadil
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Drug: Alprostadil
- Recalling firm
- Montana Compounding Pharmacy
- Origin
- MT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1128-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alprostadil recalls
See all
Class III · Low risk
Alprostadil Injection USP 500 mcg/mL
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Lack of assurance of sterility.
Class II · Moderate risk
PGE-3 Alprostadil 150 mcg/mL
Lack of assurance of sterility.
Other recalls by Montana Compounding Pharmacy
All 2015 recalls
Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (A;ph,pa)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (A;ph,pa)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
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