Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, F...
FDA Recall #D-1485-2019 — Class II — June 26, 2019
Product Description
Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
Reason for Recall
Lack of Assurance of Sterility.
Recalling Firm
First Pharma Associates LLC dba Riverpoint Pharmacy — Spokane, WA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 60 EA, b) 15mL, c) 24 EA
Distribution
ID, WA only
Code Information
Lot #: a) 06042019@20, Exp. 07/19/2019; 06052019@24, Exp. 07/28/2019; 06062019@10, Exp. 07/21/2019; b) 06132019@6, Exp. 07/29/2019; c) 06182019@28, Exp. 12/17/2019, 06192019@28, Exp. 12/18/2019.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated