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 for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.
Reported: March 18, 2015 Initiated: February 23, 2015 #D-0411-2015
Product Description
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 for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.
Reason for Recall
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Details
- Recalling Firm
- Qualitest Pharmaceuticals
- Units Affected
- 972 bottles
- Distribution
- Nationwide
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
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 for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.. Recalled by Qualitest Pharmaceuticals. Units affected: 972 bottles.
Why was this product recalled? ▼
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 18, 2015. Severity: Moderate. Recall number: D-0411-2015.
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