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Terminated

EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.

FDA Recall Z-0050-2020 · Posted 2019-10-07

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeN/A
Date Initiated2019-08-13
Date Terminated2020-11-23
Product Quantity2,719,200 dispenser units

Reason for Recall

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

Firm Action

The firm issued a safety alert on 08/13/2019 by letter. The letter explained the 5mL syringes were commingled with 3mL syringes and directed the consignee separate the 5mL syringes from the 3mL syringes.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - including US Nationwide distribution, and country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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