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 brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
Lot numbers, UPCs & expiration codes
Lot # 82507 and 82720.
Where it was sold
Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
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-419-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 4, 2013
- FDA report date
- May 29, 2013
- Quantity
- 27,144 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aaron Industries Inc
Original FDA data
Every field from FDA enforcement report D-419-2013, exactly as published.
Show all FDA fields
- City
- Lynwood
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 52863
- Address
- 11865 Alameda St
- Code information
- Lot # 82507 and 82720.
- Postal code
- 90262-4022
- Report date
- May 29, 2013
- Product type
- Drugs
- Recall number
- D-419-2013
- Classification
- Class III
- Recalling firm
- Aaron Industries Inc
- Product quantity
- 27,144 bottles
- 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 brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
- Distribution pattern
- Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
- Recall initiation date
- Apr 4, 2013
- Initial firm notification
- Letter
- Center classification date
- May 17, 2013