D-0470-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

FDA drug recall D-0470-2020 was initiated by Altaire Pharmaceuticals, Inc. on July 2, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility Affected quantity: 318,412 units.

Recall Details

Product Type
Drugs
Report Date
November 27, 2019
Initiation Date
July 2, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
318,412 units

Product Description

TRP Stye Relief, 4 g, NDC 17312-014-13

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

RHP 8/19 RLD 12/19 SDE 4/20 SID 9/20