Recalls / Class II
Class IID-0449-2020
Product
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Altaire Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 311 W Ln, PO Box 849, Aquebogue, New York 11931-0849
Distribution
- Quantity
- 427,280 units
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-07-02
- FDA classified
- 2019-11-15
- Posted by FDA
- 2019-11-27
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0449-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.