D-0354-2020 Class II
FDA drug recall D-0354-2020 was initiated by Altaire Pharmaceuticals, Inc. on July 2, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility Affected quantity: 87922 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2019
- Initiation Date
- July 2, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87922 containers
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: SEE, SEG, Exp 5/20; SIE, Exp 9/20; SKD, Exp 11/20