CLASS II Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report
Gentamicin 15 MG/ML Ophthalmic Solution, Sterile Droppers recalled
Well Care Compounding Pharmacy is recalling Gentamicin 15 MG/ML Ophthalmic Solution, Sterile Droppers, 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-0985-2016
- 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
- Eye Drops
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
GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Where it was distributed
NV
Questions about this recall
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 #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp 04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016
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 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
50 other products · FDA event 74187This product is part of a recall event; the main page for the event is Estradiol Cypionate 10 MG/ML recalled by Well Care Compounding Pharmacy.
More recalls from Well Care Compounding Pharmacy
All 51Other Gentamicin recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Ointment USP 0.1%, packaged as a) tube recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin 80mg/ Irrigation, containers recalled | The Medicine Shoppe Pharmacy | Sterility | FL |