Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Reported: February 6, 2019 Initiated: October 8, 2018 #D-0414-2019
Product Description
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Reason for Recall
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 149,159 5mL bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10. Recalled by Akorn, Inc.. Units affected: 149,159 5mL bottles.
Why was this product recalled? ▼
Presence of Particulate Matter: Crystalline particles were noticed 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-0414-2019.
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