Drug Enforcement D-0132-2023

CGMP Deviations:

Status

Ongoing

Classification

Class II

Report Date

January 25, 2023

Termination Date

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Product Information

Product description
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
Product quantity
36,025 tubes
Reason for recall
CGMP Deviations:
Recall initiation reason
—
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-0132-2023
Event ID
90948
Recall initiation date
October 13, 2022
Center classification date
January 13, 2023
Code info
Lot # 0G87A, EXP 06/30/2023
More code info
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