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Recall Observatory FDA recall evidence

Drug 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

D-0415-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
306,479 units
Official record key
drug-enforcement:D-0415-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 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

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility