Gentamicin Irrigation Recalled for Lack of Sterility Assurance
The Medicine Shoppe Pharmacy is recalling Gentamicin 80mg/60 mL Irrigation containers due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for a medical irrigation product, which poses a significant risk of infection or injury.
Plain-English summary
The Medicine Shoppe Pharmacy is recalling four bottles of Gentamicin 80mg/60 mL Irrigation. The recall is being conducted because there is a lack of assurance of sterility for the product.
The affected product is identified by code 7016542 and has a discard after date of 01/12/2021. The recall is limited to distribution in Florida.
Consumers who have this product should stop using it and contact the pharmacy for further instructions.
The recalled product
- Product
- Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
- Manufacturer
- The Medicine Shoppe Pharmacy
- Category
- Drug — Pharmacy Compounded
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 7016542
- discard after 01/12/2021
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · The Medicine Shoppe Pharmacy
See all →- SevereBi-Est Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateDiethylstilbestrol Capsules Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateHydrocortisone Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateTestosterone Gel Recalled by Florida Pharmacy for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateParegoric Alternate Elixir Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19