Why it was recalled
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Product description
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.
Lot numbers, UPCs & expiration codes
Lot #: 151631, Exp 10/15 and 152767, Exp 11/15
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-1097-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 4, 2014
- FDA report date
- Mar 12, 2014
- Quantity
- 43,921 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aaron Industries Inc
Original FDA data
Every field from FDA enforcement report D-1097-2014, exactly as published.
Show all FDA fields
- City
- Lynwood
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 67434
- Address
- 11865 Alameda St
- Code information
- Lot #: 151631, Exp 10/15 and 152767, Exp 11/15
- Postal code
- 90262-4022
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1097-2014
- Classification
- Class III
- Recalling firm
- Aaron Industries Inc
- Product quantity
- 43,921 bottles
- Termination date
- Oct 29, 2014
- Reason for recall
- Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 4, 2014
- Initial firm notification
- Telephone
- Center classification date
- Feb 28, 2014