Recalls / Class II
Class IID-0415-2019
Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
- Affected lot / code info
- Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, N/A, Grover Beach, California 93433-4221
Distribution
- Quantity
- 84, 5 ml bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-10-18
- FDA classified
- 2019-01-28
- Posted by FDA
- 2019-02-06
- Terminated
- 2021-05-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0415-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.