D-0436-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

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
102,939 units

Product Description

Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

17244 8/19 18057 3/20 518307 12/20