CLASS II Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report
Ultra-test (Cyp 80%/Prop 20%) Injectable, 250 mg/mL vial recalled
Wells Pharmacy Network is recalling Ultra-test (Cyp 80%/Prop 20%) Injectable, 250 mg/mL vial, Compounded by Wells Pharmacy, distributed nationwide in the US. The recall was initiated on 21 Sep 2016 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-0328-2017
- FDA event ID
- 75289
- Recalling firm
- Wells Pharmacy Network, Ocala, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2016
- FDA classified
- 4 Jan 2017
- Reported
- 11 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Sep 2016 | Recall initiated by company | |
| 4 Jan 2017 | Classified by FDA | +105 days |
| 11 Jan 2017 | 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
Lack of Assurance of Sterility
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
ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Where it was distributed
Nationwide
Questions about this recall
Is Ultra-test (Cyp 80%/Prop 20%) Injectable, 250 mg/mL vial, Compounded by Wells Pharmacy recalled?
Yes. Wells Pharmacy Network recalled Ultra-test (Cyp 80%/Prop 20%) Injectable, 250 mg/mL vial, Compounded by Wells Pharmacy on 21 Sep 2016. The recall is Class II and its status is Terminated. Recall number D-0328-2017.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known Lot No. 03282016@22, 05162016@5, 07252016@16. Known lot codes: 03282016@22, 05162016@5, 07262016@16
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.
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|---|---|---|---|---|---|
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