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 mgDextromethorphan Hydrobromide 15 mgalcohol 7%ONE PINT (574 mL)Rx only
- Manufactured forQUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- NDC0603-1586-58
- Lot codes and dates
Lot #: 0000001099Exp. 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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