GENTAMICIN OPTH-SOL 5ml Compare: Garamycin — Class II drug recall D-0415-2019
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2019-02-06, distributed nationwide. Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity tes
| Recall number | D-0415-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2018-10-18 |
| Classified | 2019-01-28 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2021-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 84 |
| Reason classes | specification failure |
| NDC | 17478-0283-10, 52959-0103-00 |
| Lot numbers | 02/19, 3/20, GNT01AK, GNT07AK |
Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Reason for recall
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0415-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.