FDA-Drug2019-02-06Class II

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

H J Harkins Company Inc dba Pharma Pac
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
84, 5 ml bottles
Manufactured in
1400 W Grand Ave Ste F, N/A, Grover Beach, CA, United States
Products
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0415-2019

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