FDAFDA · Food and drugs·Recall number D-0985-2016
GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Published June 15, 2016 · Recall initiated: May 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Well Care Compounding Pharmacy
- Distributor
- NV
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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