Recalls / Class II
Class IID-0422-2020
Product
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-05
- Brand name
- Fluorescein Sodium And Proparacaine Hydrochloride
- Generic name
- Fluorescein Sodium And Proparacaine Hydrochloride
- Active ingredients
- Fluorescein Sodium, Proparacaine Hydrochloride
- Route
- Ophthalmic
- NDC
- 59390-205
- Affected lot / code info
- 17099 4/20 6/1/2017 17254 8/20 9/14/2017 17255 8/20 9/15/2017 17361 12/20 12/26/2017 17362 12/20 4/4/2018 18088 4/21 4/30/2018 18089 4/21 5/1/2018 18138 6/21 6/25/2018 18146 6/21 6/29/2018 18156 6/21 8/6/2018 18212 8/21 10/2/2018 18276 11/21 12/26/2018 19082 3/22 5/1/2019 19098 4/22 5/21/2019 16282 10/19 11/11/2016 16283 10/19
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Altaire Pharmaceuticals, Inc.
- Manufacturer
- 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
- 532,961 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-0422-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.