GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

FDA recall notice · announced February 6, 2019 · H J Harkins Company Inc Dba Pharma Pac

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

Reason for recall

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
Quantity: 84, 5 ml bottles
Status: Terminated
Products in this recall event:
- GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00 (D-0415-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.