Baby Care Products

JANUARY 27, 2012

Johnson & Johnson Consumer Companies, Inc. is voluntarily recalling from retailers one lot of AVEENO^® BABY CALMING COMFORT^® LOTION (full product details below) in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas. This is not a consumer level recall and no action is required by consumers.

This recall is being initiated as a precautionary measure after testing of a product sample by the U.S. Food and Drug Administration (FDA). That test indicated that the lot exceeded the specifications for common bacteria, though extensive testing by an independent laboratory afterward did not show that specifications were exceeded. However, Johnson & Johnson Consumer Companies, Inc. has voluntarily initiated this recall out of an abundance of caution. This action is not being undertaken on the basis of adverse events and the potential for adverse health effects is remote. Other lots of AVEENO^® BABY CALMING COMFORT^® LOTION are not affected by this recall and remain available.

This recall is being conducted with the knowledge of the FDA.

Consumers who would like a refund or coupon, or who have questions or concerns about the recalled product, should call our Consumer Call Center at 1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).

The lot number and UPC code for the recalled product is embossed on the tube.

FULL RECALLED PRODUCT LIST:

FREQUENTLY ASKED QUESTIONS:

1. Q: Why are you recalling these products?
   A: Johnson & Johnson Consumer Companies, Inc. is initiating this retail-level recall as a precautionary measure after post release testing of a product sample by the U.S. Food and Drug Administration (FDA). That test indicated that one lot exceeded the specifications for common bacteria, though extensive testing by an independent laboratory afterward did not show that specifications were exceeded. However, Johnson & Johnson Consumer Companies, Inc. has voluntarily initiated this recall out of an abundance of caution. This action is not being undertaken on the basis of adverse events and the potential for adverse health effects is remote. Other lots of AVEENO^® BABY CALMING COMFORT^® LOTION are unaffected by this recall and may remain available.
2. Q: Can consumers continue to use their AVEENO^® Baby Calming Comfort^® Lotion?
   A: Consumers do not need to take action and the potential for adverse health effects is remote. Of course, anyone who has concerns or is uncomfortable using the product may discontinue use and call our Consumer Call Center at 1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time) to have their questions answered or to receive a refund.
3. Q: Are there health effects associated with the reason for this recall?
   A: This action is not being undertaken on the basis of adverse events and the potential for adverse health events is remote. No action is required by consumers; however, if consumers have questions or would like a refund, they should call our Consumer Call Center at 1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time). Other lots of AVEENO^® BABY CALMING COMFORT^® LOTION are unaffected by this recall and may remain available.
4. Q: Should consumers return this product?
   A: Consumers do not need to take action and the potential for adverse health effects is remote. However, if consumers have questions or would like a refund, they should call our Consumer Call Center at 1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).
5. Q: Will you provide consumers with a refund?
   A: Yes, we will offer consumers a refund. Consumers do not need to take action and the potential for adverse health effects is remote. However, anyone who has concerns or is uncomfortable using the product may discontinue use and call our Consumer Call Center at 1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time) to have their questions answered or to receive a refund.