Altaire Pharmaceuticals, Inc.: Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. A

Is my product affected?

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 FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Altaire Pharmaceuticals, Inc. is recalling Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile) distributed nationwide in the United States. The recall affects 532,961 units across multiple lots manufactured between October 2016 and April 2019 due to a lack of assurance of sterility.

The source document does not specify what an affected consumer should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Lack of Assurance of Sterility

Details from the source

Reason for recall: Lack of Assurance of Sterility Distribution: U.S.A. Nationwide Quantity: 532,961 units 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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