CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
PGE-1, 100 mcg/mL Injection in Normal Saline recalled
University Compounding Pharmacy is recalling PGE-1, 100 mcg/mL Injection in Normal Saline, University Compounding Pharmacy, distributed nationwide in the US. The recall was initiated on 6 Sep 2013 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-1024-2013
- FDA event ID
- 66206
- Recalling firm
- University Compounding Pharmacy, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Sep 2013 | Recall initiated by company | |
| 12 Sep 2013 | Classified by FDA | +6 days |
| 18 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.
Where it was distributed
Nationwide
Questions about this recall
Is PGE-1, 100 mcg/mL Injection in Normal Saline, University Compounding Pharmacy recalled?
Yes. University Compounding Pharmacy recalled PGE-1, 100 mcg/mL Injection in Normal Saline, University Compounding Pharmacy on 6 Sep 2013. The recall is Class II and its status is Terminated. Recall number D-1024-2013.
Why was it recalled?
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Which lots are affected?
Lot #: 497930, 11/5/2013
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from University Compounding Pharmacy
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone CYP (Sesame Oil) 200mg/mL Injection Vial recalled | University Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | PGE-1, 20 mcg/mL Injection in Normal Saline recalled | University Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate (Sesame Oil) 200mg/mL Injection Vial recalled | University Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL recalled | University Compounding Pharmacy | Sterility | Nationwide |