Why it was recalled
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
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.
Lot numbers, UPCs & expiration codes
Lot #: 0000001099; Exp. 03/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0411-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 23, 2015
- FDA report date
- Mar 18, 2015
- Quantity
- 972 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0411-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 70598
- Address
- 120 Vintage Dr NE
- Code information
- Lot #: 0000001099; Exp. 03/16
- Postal code
- 35811-8216
- Report date
- Mar 18, 2015
- Product type
- Drugs
- Recall number
- D-0411-2015
- Classification
- Class II
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 972 bottles
- Termination date
- Jul 12, 2016
- Reason for recall
- Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2015