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GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-1...

FDA Recall #D-0415-2019 — Class II — October 18, 2018

Recall #D-0415-2019 Date: October 18, 2018 Classification: Class II Status: Terminated

Product Description

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

Reason for Recall

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

Recalling Firm

H J Harkins Company Inc dba Pharma Pac — Grover Beach, CA

Classification

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

Product Type

Drugs

Product Quantity

84, 5 ml bottles

Distribution

Nationwide in the USA and Puerto Rico

Code Information

Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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