Drug Enforcement D-0158-2023

CGMP Deviations:

Status

Ongoing

Classification

Class II

Report Date

January 25, 2023

Termination Date

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Product Information

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
Product quantity
91,692 bottles
Reason for recall
CGMP Deviations:
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Akorn, Inc.
Address
5605 Centerpoint Ct Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0158-2023
Event ID
90948
Recall initiation date
October 13, 2022
Center classification date
January 13, 2023
Code info
Lot: 1D94A, EXP 3/31/2023; 1E35A, EXP 4/30/2023; 2A06A, EXP 12/31/2023
More code info
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