PlainRecalls
FDA Drug Moderate Class II Completed

Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35

Reported: November 27, 2019 Initiated: July 2, 2019 #D-0355-2020

Product Description

Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
261,528 units
Distribution
U.S.A. Nationwide
Location
Aquebogue, NY

Frequently Asked Questions

What product was recalled?
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 261,528 units.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0355-2020.