Recalls / Class II
Class IID-0415-2020
Product
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13
- Affected lot / code info
- 17205 07/19 08/31/2017 17206 07/19 09/13/2017 17271 09/19 11/08/2017 18003 01/20 03/06/2018 18097 04/20 05/11/2018 18166 07/20 07/26/2018 18227 09/20 10/05/2018 18246 10/20 11/16/2018 18317 12/20 12/18/2018 19080 03/21 04/22/2019 19106 04/21
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
- 306,479 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-0415-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.