CLASS II Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report
Tri-mix # 5, packaged in 5 mL vials, Rx only, Well Care Compounding recalled
Well Care Compounding Pharmacy is recalling Tri-mix # 5, packaged in 5 mL vials, Rx only, Well Care Compounding, distributed in Nevada. The recall was initiated on 17 May 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-1020-2016
- FDA event ID
- 74187
- Recalling firm
- Well Care Compounding Pharmacy, Las Vegas, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2016
- FDA classified
- 9 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 May 2016 | Recall initiated by company | |
| 9 Jun 2016 | Classified by FDA | +23 days |
| 15 Jun 2016 | 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: FDA inspection identified GMP violations potentially impacting product quality and 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
TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Where it was distributed
NV
Questions about this recall
Is Tri-mix # 5, packaged in 5 mL vials, Rx only, Well Care Compounding recalled?
Yes. Well Care Compounding Pharmacy recalled Tri-mix # 5, packaged in 5 mL vials, Rx only, Well Care Compounding on 17 May 2016. The recall is Class II and its status is Terminated. Recall number D-1020-2016.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Which lots are affected?
Lot #: 12302015:53@18, Exp.04/29/2016; Lot #: 03142016:67@53, Exp. 06/12/2016; Lot #: 03302016: 43@38, Exp. 06/28/2016; Lot #: 03/292016: 30@23, Exp. 06/29/2016.
Where was it sold?
NV
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.