RSD, Chronic Pain

Safety Alert: Voluntary Recall
September 28, 2009

McNeil Consumer Healthcare, the Maker of Children’s Tylenol®, Announces a Voluntary Recall</[>

After discovering the possible contamination with Gram-negative bacteria, Burkholderia cepacia, McNeil Consumer Healthcare, a division of Johnson & Johnson, informed physicians and other providers of the recall in a September 18, 2009 letter. The company reported that no bacteria had been found in finished products, but bacteria were detected in an examination of the bulk materials used to make the medicine.
McNeil cautioned that infection with the bacteria can be serious in high-risk persons, including those with pulmonary disease, cystic fibrosis, or immune systems that are otherwise compromised. Young children and elders using these preparations for pain control should be warned.

The recall covers 21 flavors of its pediatric acetaminophen product, and several cold and cough medications that include acetaminophen, manufactured from April 2008 through June 2008, which includes:

• Children’s Tylenol® Suspension 4 oz. strawberry,

• Children’s Tylenol® Pediatric Suspension 1 oz. cherry

• Infants’ Tylenol® Suspension Drops 1/2 oz. grape

• For the complete list and associated lot numbers, see: http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc.

Individuals who may have these medicines in their possession should:

• Stop taking this preparation if listed above.

• Contact your health care professional (HCP) if you or your child taking this medication has become suddenly ill

  • Symptoms of exposure can range from no symptoms to severe breathing difficulties especially in those with chronic lung disorders. For more information, visit the CDC website: http://www.cdc.gov/ncidod/dhqp/id_BcepaciaFS.html

• Share this information with your HCP, pharmacist and insurance provider should there be additional questions.

The recall does NOT apply to children’s Tylenol® Meltaways or Junior Strength Tylenol® Meltaways.

McNeil has established a consumer call center at 800-962-5357 for parents or caregivers with questions.

APF URGES YOU TO READ THIS ALERT AND TAKE ACTION TODAY!

To:  All individuals and organizations who care about access to pain care in America.

URGENT CALL TO ACTION!

The Federal Drug Administration (FDA) may remove important pain medications from the market or could very likely limit access to certain pain medications that are currently legally prescribed to millions of Americans suffering from pain.

The FDA needs to hear how vital access to these medications is to people with pain and what tragic results could occur if they were denied access to these medications or if additional barriers were created making access more difficult for people who are legally prescribed these medications.

ACTION REQUESTED

Send a letter to the FDA sharing your story about how their decisions would impact you or your loved one.  The FDA MUST receive your letters by Tuesday, June 30th, so don’t delay.

Please review the following to assist in your letter writing and to provide further information on the issue:

• Frequently Asked Questions

• Risk Evaluation and Mitigation Strategy (REMS) Consumer Talking Points

• American Pain Foundation’s Position Statement on REMS

• American Pain Foundation’s Recommendations on REMS

Click here to go directly to the FDA comment submission page to submit your letter electronically or mail your letters to:

Division of Dockets Management (HFA305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Please Note:  All letters sent electronically or through the mail must clearly include the following information at the top of your letter: Docket No. FDA-2009-N-0143. Please send a copy of your letter to advocacy@painfoundation.org so we can also have an opportunity to hear your commentary.

Testimony of Pain Advocates at FDA Hearing, May 27th and 28th. These testimonies may also help you write your letter.

• Mark Maginn 

• Carolyn Noel

• Teresa Shaffer 

• Mary Vargas

FDA’s REMS Information

THANK YOU FOR SUBMITTING YOUR LETTER AND ALLOWING YOUR VOICE TO BE HEARD!

Sincerely,

American Pain Foundation