Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason 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
What was recalled
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
- 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Alprostadil recalls
See all
Class III · Low risk Terminated
Alprostadil Injection USP 500 mcg/mL
Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk Completed
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
PGE-3 Alprostadil 150 mcg/mL
Reason Lack of assurance of sterility.
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