FDA Drug recall D-0415-2019
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10
- FDA Drug
- Class II
- terminated
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class II recall of GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10 by H J Harkins, citing presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0415-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-18 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | H J Harkins |
| Distribution | US |
Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Reason
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Identifiers
| code_info | Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0415-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.