Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Reported: January 25, 2023 Initiated: October 13, 2022 #D-0158-2023
Product Description
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Reason for Recall
CGMP Deviations:
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 91,692 bottles
- Distribution
- Nationwide in the USA
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05. Recalled by Akorn, Inc.. Units affected: 91,692 bottles.
Why was this product recalled? ▼
CGMP Deviations:
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0158-2023.
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