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
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
Lot numbers, UPCs & expiration codes
Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307
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-186-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 18, 2013
- FDA report date
- Mar 13, 2013
- Quantity
- 35,652 bottles (2,971 cases)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aaron Industries Inc
Original FDA data
Every field from FDA enforcement report D-186-2013, 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# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307
- Postal code
- 90262-4022
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-186-2013
- Classification
- Class III
- Recalling firm
- Aaron Industries Inc
- Product quantity
- 35,652 bottles (2,971 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
- Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
- 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