Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- October 8, 2018
- Posted
- February 6, 2019
- Recall Number
- D-0414-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 149,159 5mL bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020
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