Reported Feb 6, 2019 · Terminated

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: H J Harkins Company Inc dba Pharma Pac · 1400 W Grand Ave Ste F · Grover Beach, CA · 93433-4221

Is this the product you have?

  • GENTAMICIN OPTH-SOL 5ml CompareGaramycin. 5-mL plastic dropper bottle
  • MfgAKORN 17478-0283-10. NDC 52959-0103-00
Lot codes and dates
    • Lot # GNT01AK
    • Exp. 02/19 & GNT07AK
    • Exp. 3/20
Amount recalled
84, 5 ml bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new H J Harkins Company Inc. dba Pharma Pac recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 6, 2021 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.