Drug product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
D-0415-2019
Product summary
- Event
- Event 81343
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84, 5 ml bottles
- Official record key
drug-enforcement:D-0415-2019
Official wording
Reason: Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Code information: Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter