FDAFDA · Food and drugs·Recall number D-0415-2019
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Published February 6, 2019 · Recall initiated: October 18, 2018
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
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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