Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle Recalled by H J Harkins Company Inc dba Pharma Pac Due to Presence of Particulate Matter: Crystalline particles were noticed...

Date: October 18, 2018
Company: H J Harkins Company Inc dba Pharma Pac
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact H J Harkins Company Inc dba Pharma Pac directly.

Affected Products

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

Quantity: 84, 5 ml bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About H J Harkins Company Inc dba Pharma Pac

H J Harkins Company Inc dba Pharma Pac has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report