CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report
Gentamicin Opth-sol Compare: Garamycin recalled by H J Harkins Company
H J Harkins is recalling Gentamicin Opth-sol Compare: Garamycin, distributed nationwide in the US. The recall was initiated on 18 Oct 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0415-2019
- FDA event ID
- 81343
- Recalling firm
- H J Harkins, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2018
- FDA classified
- 28 Jan 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 18 Oct 2018 | Recall initiated by company | |
| 28 Jan 2019 | Classified by FDA | +102 days |
| 6 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Product as listed by the FDA
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Which lots are affected?
Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from H J Harkins
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen and Codeine Phosphate recalled by H J Harkins Company | H J Harkins | Manufacturing (CGMP) Deviations | AZ, CA |
| Drug | CLASS II | Acetaminophen 500 mg tablet packaged in a) 30-count bottles recalled | H J Harkins | Packaging Defects | Nationwide |
| Drug | CLASS II | Ranitidine, a), b), c), d), e) recalled by H J Harkins Company | H J Harkins | Nitrosamine Impurity | 4 states |
| Drug | CLASS II | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g recalled | H J Harkins | Manufacturing (CGMP) Deviations | CA |
| Drug | CLASS II | Diphenhydramine HCL Liquid, 12.5 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |