Reported Feb 6, 2019 · Terminated
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
H J Harkins Company Inc. dba Pharma Pac
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: H J Harkins Company Inc dba Pharma Pac · 1400 W Grand Ave Ste F · Grover Beach, CA · 93433-4221
Is this the product you have?
- GENTAMICIN OPTH-SOL 5ml CompareGaramycin. 5-mL plastic dropper bottle
- MfgAKORN 17478-0283-10. NDC 52959-0103-00
- Lot codes and dates
Lot # GNT01AKExp. 02/19 & GNT07AKExp. 3/20
- Amount recalled
- 84, 5 ml bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
This product could cause temporary or reversible health problems — stop using it.
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