FDA recall D-0415-2019

H J Harkins Company Inc dba Pharma Pac · Class II · drug

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.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2018-10-18
Report date
2019-02-06
Termination date
2021-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grover Beach, CA, United States

Primary source

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