Drug recall
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC…
FDA recall event 81343 · Class II · H J Harkins Company Inc dba Pharma Pac
Key facts
| Event ID | 81343 |
|---|---|
| Recall numbers | D-0415-2019 |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac |
| Product type | Drugs |
| Products | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. |
| Initiation date | Oct 18, 2018 |
| Report date | Feb 6, 2019 |
| Termination date | May 6, 2021 |
| City | Grover Beach |
| State | CA |
| Country | United States |
| FEI number | 2024390 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: