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ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared ...

FDA Recall #D-0712-2017 — Class II — April 18, 2017

Recall #D-0712-2017 Date: April 18, 2017 Classification: Class II Status: Terminated

Product Description

ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reason for Recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Recalling Firm

Key Pharmacy and Compounding Center — Federal Way, WA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

9 mL

Distribution

Distributed nationwide in U.S.A., Australia and Canada.

Code Information

Lot # t01-26-2017@93, Exp 4/27/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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