CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy recalled
Westlab Pharmacy is recalling Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607, distributed nationwide in the US. The recall was initiated on 10 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0089-2019
- FDA event ID
- 80838
- Recalling firm
- Westlab Pharmacy, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2018
- FDA classified
- 24 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Aug 2018 | Recall initiated by company | |
| 24 Oct 2018 | Classified by FDA | +75 days |
| 31 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Product Formulation
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Incorrect Product Formulation
Which lots are affected?
Lot: 03192018@42 Discard after 9/15/2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 80838This product is part of a recall event; the main page for the event is Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc. recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc. recalled | Westlab Pharmacy | Other | Nationwide | |
| CLASS II | ADAA Cataract Drops, (Lido recalled by Westlab Pharmacy | Westlab Pharmacy | Other | Nationwide |
More recalls from Westlab Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ADAA Cataract Drops, (Lido recalled by Westlab Pharmacy | Westlab Pharmacy | Other | Nationwide |
| Drug | CLASS II | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc. recalled | Westlab Pharmacy | Other | Nationwide |
Other Alprostadil recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS III | Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alprostadil 25mcg/ML 25mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 32mcg/ML 32mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 30mcg/ML Inj 30mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |