FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Johnson and Johnson–Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants’ Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments

Media Contact:

Marc Boston

215-273-7649 (office)

215-429-7034 (mobile)

Bonnie Jacobs

215-273-8994  (office)

856-912-9965 (mobile)

FOR IMMEDIATE RELEASE — Fort Washington, PA (November 7, 2008) – Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants’ MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Infants’ MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants’ MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: Use postage-paid FDA form 3500 available at:

www.fda.gov/MedWatch/getforms.htm.

Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

©2012 An Inconvenient Woman. All Rights Reserved.

The Food and Drug Administration (FDA) is warning people not to use or buy Mommy’s Bliss Nipple Cream because the product contains potentially harmful ingredients that may cause respiratory problems or vomiting and diarrhea in infants.

Marketed by MOM Enterprises Inc. in San Rafael, Calif., the product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. The product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, FDA is alerting the public because of the potential harm this product could have on nursing infants. To date, no injuries to infants have been reported to FDA.

Potentially Harmful Ingredients

The two potentially harmful ingredients in Mommy’s Bliss Nipple Cream are chlorphenesin and phenoxyethanol, which may interact with one another to further increase the risk of slow or shallow breathing (respiratory depression) in nursing infants.

Chlorphenesin

• relaxes skeletal muscle
• can depress the central nervous system and cause respiratory depression in infants
• can cause a skin condition that can worsen the drying and cracking of nipple skin (dermatitis) in mothers

Phenoxyethanol

• is a preservative that is primarily used in cosmetics and medications
• can depress the central nervous system
• may cause vomiting and diarrhea, which can lead to dehydration in infants

Signs to Watch For

Get immediate medical attention if your child is showing the following signs and symptoms or if you are having difficulty awakening the child:

• decrease in appetite
• limpness of extremities or decrease in strength of grip and
• a change in skin color

What Consumers Should Do

• Discontinue use of Mommy’s Bliss Nipple Cream.
• Consult a health care professional if you experience problems or believe your infant may have experienced problems due to the product.
• Speak with your health care professional or certified lactation consultant if your nipples are cracked or painful.
• Report adverse events related to the product to MedWatch at www.fda.gov/medwatch/report.htm or by calling 800-332-1088.

For More Information

FDA Press Release

www.fda.gov/bbs/topics/NEWS/2008/NEW01839.html

FDA MedWatch Web site

www.fda.gov/medwatch/

Date Posted: May 30, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

Company manufactures and distributes unapproved and adulterated drugs

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

“The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

“The FDA will take action against companies and their executives who violate the law and endanger public health,” said Margaret O’K. Glavin, associate commissioner for Regulatory Affairs. “The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs—Compliance Policy Guide” (CPG).  This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. The CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland.

For more information:

FDA’s ongoing efforts on marketing unapproved drugs

CDER’s Web page on Compliance with Current Good Manufacturing Practices

©2012 An Inconvenient Woman. All Rights Reserved.

Pokémon Branded “Valentine Cards and Pops” —Because They May Contain Metal Fragments

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

FOR IMMEDIATE RELEASE — Rockville, MD — February 14, 2008 – Sherwood Brands LLC is voluntarily recalling approximately 400,000 packages of Pokémon® branded “Valentine Cards and Pops™” (Item# 073964209109 and Item# 073964289804), because of reports that metal fragments were found in two lollipops purchased in Florida. There are no reports of injury. People who bite into or swallow a metal fragment could possibly be injured.

The products being recalled are packages of ten and thirty Pokémon branded Valentine cards and lollipops featuring a variety of characters.

Sherwood Brands is advising its distribution network to remove the Pokémon branded Valentine cards and lollipops from the shelves immediately. The product was sold at retailers nationwide.

“Our utmost concern is the safety of our customers. We took immediate action upon learning of this incident and Sherwood is working with the FDA to recall the products,” said Amir Frydman, president of Sherwood Brands.

“Pokémon is committed to consumer safety and we’re working closely with our licensee, Sherwood Brands, to investigate this matter completely,” said J.C. Smith, Pokémon USA’s director of marketing.

Consumers who have purchased the above products are advised not to consume them and to return them to Sherwood Brands for a full refund. Send affected products to:

Sherwood Brands LLC

Attn: Product Recall

350 Shaw Drive,

Keysville, VA 23947

Press ReleaseContact:

Amir Frydman

Sherwood Brands LLC

(301) 309-6161 x19

©2012 An Inconvenient Woman. All Rights Reserved.