Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter
H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter in an ophthalmic solution without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
H J Harkins Company Inc dba Pharma Pac is recalling 84 bottles of Gentamicin Ophthalmic Solution, 5 mL. The product is identified by NDC 52959-0103-00 and was distributed nationwide in the USA and Puerto Rico.
The recall was initiated because crystalline particles were noticed by the manufacturer during 24-month clarity testing. The affected lots are GNT01AK with an expiration date of 02/19 and GNT07AK with an expiration date of 3/20.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Category
- Drug — Ophthalmic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # GNT01AK
- Exp. 02/19 & GNT07AK
- Exp. 3/20
Distribution
Related recalls
Same manufacturer · H J Harkins Company Inc dba Pharma Pac
See all →- ModerateFDA Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2020-04-22
- HighAcetaminophen Tablets Recalled Due to Foreign Tablet Contamination
FDA (Drugs) · 2020-03-18
- SevereRanitidine Tablets Recalled Due to NDMA Impurity Detection
FDA (Drugs) · 2020-01-29
- ModeratePharma Pac Recalls Neomycin Ophthalmic Ointment for Quality Control Issues
FDA (Drugs) · 2019-08-07
- SevereDiphenhydramine Liquid Recalled for Potential Microbial Contamination
FDA (Drugs) · 2019-07-03
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateAkorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter
FDA (Drugs) · 2019-02-06
- SevereAkorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities
FDA (Drugs) · 2019-03-20
- SevereGentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
- ModerateActavis Recalls Levofloxacin Ophthalmic Solution Due to Impurity Failure
FDA (Drugs) · 2017-03-15
- ModerateActavis Recalls Ciprofloxacin Ophthalmic Solution Due to Impurity
FDA (Drugs) · 2016-07-06
- ModerateGatifloxacin Ophthalmic Solution Recall Due to Failed Stability Testing
FDA (Drugs) · 2022-01-12