Class II · Moderate risk
Alprostadil Container Description: Amber color bottle
CGMP Deviations
Alprostadil 500 mcg/mL Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect Product Formulation
Cause type: Other
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.
What was recalled
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Affected NDC
10002-7335-00
Compare with the code on your package — it is the most precise check available.
Drug: Alprostadil
- Recalling firm
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
- NDC code
- 10002-7335-00
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0089-2019 · 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 Westlab Pharmacy, Inc. dba Westlab Pharmacy
All 2018 recalls
Class II · Moderate risk
Cyclosporine 1% Human Eye Drops
Lack of Process Controls
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
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