Why it was recalled
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product description
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
Lot numbers, UPCs & expiration codes
Lot# 81198, 82183, 80797; FP-44-081-03884,
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-188-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 18, 2013
- FDA report date
- Mar 13, 2013
- Quantity
- 43,464 bottles (3,622 cases)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aaron Industries Inc
Original FDA data
Every field from FDA enforcement report D-188-2013, exactly as published.
Show all FDA fields
- City
- Lynwood
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64298
- Address
- 11865 Alameda St
- Address (line 2)
- 11840 S Alameda ST
- Code information
- Lot# 81198, 82183, 80797; FP-44-081-03884,
- Postal code
- 90262-4022
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-188-2013
- Classification
- Class III
- Recalling firm
- Aaron Industries Inc
- Product quantity
- 43,464 bottles (3,622 cases)
- Termination date
- Nov 1, 2013
- Reason for recall
- Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 18, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 7, 2013