D-0132-2023 Class II Ongoing
FDA drug recall D-0132-2023 was initiated by Akorn, Inc. on Oct 13, 2022 and is designated Class II. Reason for recall: CGMP Deviations: The recall status is ongoing. Affected quantity: 36,025 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Oct 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,025 tubes
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
Reason for Recall
CGMP Deviations:
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 0G87A, EXP 06/30/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0132-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026