GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Reported: February 6, 2019 Initiated: October 18, 2018 #D-0415-2019
Product Description
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Reason for Recall
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Details
- Recalling Firm
- H J Harkins Company Inc dba Pharma Pac
- Units Affected
- 84, 5 ml bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Grover Beach, CA
Frequently Asked Questions
What product was recalled? ▼
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 84, 5 ml bottles.
Why was this product recalled? ▼
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 6, 2019. Severity: Moderate. Recall number: D-0415-2019.
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