Drug product
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35
D-0354-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 87922 containers
- Official record key
drug-enforcement:D-0354-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: SEE, SEG, Exp 5/20; SIE, Exp 9/20; SKD, Exp 11/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility