Why it was recalled
Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
Product description
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Lot numbers, UPCs & expiration codes
Lot #: 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206
Where it was sold
IL
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-1387-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2012
- FDA report date
- Jun 27, 2012
- Quantity
- 11,688 gallon bottles (2,922 cases)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kutol Products Co Inc
Original FDA data
Every field from FDA enforcement report D-1387-2012, exactly as published.
Show all FDA fields
- City
- Cincinnati
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 61960
- Address
- 7650 Camargo Rd
- Code information
- Lot #: 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206
- Postal code
- 45243-3108
- Report date
- Jun 27, 2012
- Product type
- Drugs
- Recall number
- D-1387-2012
- Classification
- Class II
- Recalling firm
- Kutol Products Co Inc
- Product quantity
- 11,688 gallon bottles (2,922 cases)
- Termination date
- Dec 4, 2012
- Reason for recall
- Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
- Distribution pattern
- IL
- Recall initiation date
- May 21, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 18, 2012