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
Reported: January 25, 2023 Initiated: October 13, 2022 #D-0132-2023
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:
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 36,025 tubes
- Distribution
- Nationwide in the USA
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 36,025 tubes.
Why was this product recalled? ▼
CGMP Deviations:
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0132-2023.
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