Reported Sep 4, 2019 · Terminated

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

Baxter Healthcare Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • EXACTAMED Oral Dispensers, 5mL
  • AMBER
    • PHARMACY PACK
    • REF H9388505
    • x500 PHARMACY PACK
    • REF H9388105
    • x100 COST CONTAINMENT
    • REF H93884205
    • x1500
Lot codes and dates
  • REF H9388105
  • Lot Numbers
    • B301N017P
    • B301N070P
    • B302M338P
    • B304N045P REF H9388505
  • Lot Numbers
    • B301N023P
    • B301N049P
    • B302N077P REF H93884205
  • Lot Numbers
    • B301N056P
    • B302M333P
    • B303N042P
    • B307N015P
Amount recalled
2192000 syringes

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 2, 2020 · Data as of Sep 19, 6:53 PM UTC

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