D-0473-2020 Class II
FDA drug recall D-0473-2020 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: 273,100 units.
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
- 273,100 units
Product Description
Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
RJH 10/19 SCC 3/21 SGA 7/21 SGH 7/21 SHH 8/21 SLL 12/21 TAC 1/22