Recalls / Class II

Class IID-0132-2023

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

Affected lot / code info

Lot # 0G87A, EXP 06/30/2023

Why it was recalled

CGMP Deviations:

Recalling firm

Firm

Akorn, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278

Distribution

Quantity

36,025 tubes

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2022-10-13

FDA classified

2023-01-13

Posted by FDA

2023-01-25

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0132-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.