Gentamicin Ophthalmic Solution (Pharma Pac) – Crystalline Particles (2018)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Brand
H J Harkins Company Inc dba Pharma Pac
Lot Codes / Batch Numbers
Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
Products Sold
Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
H J Harkins Company Inc dba Pharma Pac is recalling GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. due to Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026