D-0449-2020 Class II
FDA drug recall D-0449-2020 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: 427,280 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
- 427,280 units
Product Description
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
17255 8/20 17362 12/20 18089 4/21 18138 6/21 6/22/2018 18146 6/21 18210 8/21 18211 8/21 18272 11/21 18273 11/21 18276 11/21 16283 10/31/2019