Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500

FDA Recall Z-2432-2019 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKYX
Date Initiated2019-06-27
Date Terminated2020-11-02
Product Quantity2192000 syringes

Reason for Recall

EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.

Firm Action

The firm disseminated a safety alert to their consignees on 06/27/2019 by letter. The letter explained the 5mL syringes were commingled with 10mL syringes and directed the consignee separate the 5mL syringes from the 10mL syringes.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

↑