Reported Mar 18, 2015 · Terminated

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE…

Qualitest Pharmaceuticals

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216

Is this the product you have?

  • PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP)
  • EACH 5 ml (ONE TEASPOONFUL) CONTAINS
    • Promethazine Hydrochloride 6.25 mg
    • Dextromethorphan Hydrobromide 15 mg
    • alcohol 7%
    • ONE PINT (574 mL)
    • Rx only
  • Manufactured forQUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
  • NDC0603-1586-58
Lot codes and dates
    • Lot #: 0000001099
    • Exp. 03/16
Amount recalled
972 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 12, 2016 · Data as of Sep 19, 7:57 PM UTC

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