H J Harkins Company Inc dba Pharma Pac recalls GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
- Recall date
- October 18, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0415-2019
- FDA classification
- Class II
- Brand / firm
- H J Harkins Company Inc dba Pharma Pac
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
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