CLASS II Drug recall · Reported 8 Apr 2020 · FDA Enforcement Report
Gentamicin 80mg/ Irrigation, containers recalled
The Medicine Shoppe Pharmacy is recalling Gentamicin 80mg/ Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port, distributed in Florida. The recall was initiated on 16 Mar 2020 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-1072-2020
- FDA event ID
- 85234
- Recalling firm
- The Medicine Shoppe Pharmacy, Port Charlotte, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2020
- FDA classified
- 31 Mar 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 16 Mar 2020 | Recall initiated by company | |
| 31 Mar 2020 | Classified by FDA | +15 days |
| 8 Apr 2020 | Published in enforcement report | +8 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
Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
Where it was distributed
Florida
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
7016542, discard after 01/12/2021
Where was it sold?
Florida
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.
More recalls from The Medicine Shoppe Pharmacy
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Mouth Rinse 0.05% Solution, Rx recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Bi-Est (1 /Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Naltrexone (Loxoral) recalled by The Medicine Shoppe Pharmacy | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Bi-Est (1 Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Bi-Est (8 /Progesterone 2/100 mg/mL capsule 90 caps, Rx recalled | The Medicine Shoppe Pharmacy | Other | FL |
Other 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 120 mg/ 0.9% Sodium Chloride recalled | Anderson Compounding Pharmacy | Sterility | Nationwide |