Drug product
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
D-0132-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36,025 tubes
- Official record key
drug-enforcement:D-0132-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot # 0G87A, EXP 06/30/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations