Rolaids Recall are making antacids harder to find

from USA Today…

Recalls of more than a dozen types of antacids — including brand names such as Rolaids, Pepcid and Mylanta — have left store shelves empty, retailers scrambling to increase production of store-brand knockoffs and consumers wondering what’s going on.

And relief may not come soon.

A string of recalls throughout 2010 all involved Johnson & Johnson products. Recalled Pepcid products are slowly being restocked, but others are out indefinitely, pending approval from the U.S. Food and Drug Administration.

The recalled products’ absence also has put pressure on competitors — such as Tums and store brand antacids — to ramp up production to keep up with increased demand.

“The Kroger brand has experienced a significant increase in demand — a significant enough increase that at times we’ve struggled to keep up in terms of supply,” says John Elliott, a spokesman with Kroger, which just last month created its own Rolaids-equivalent brand in response to the recalls.

In addition, the grocer stepped up production of store brands that were competitors to the other recalled Johnson & Johnson products.

At CVS, the drugstore chain is unabashedly promoting its own brand.

An empty shelf at its Fortville, Ind., location, where Pepcid AC should have been, instead had a sign that read: “Looking for Pepcid AC products? Try CVS/pharmacy Brand for the same great results.”

Joe Culp, a three- to four-times-a-week antacid user, did just that.

It wasn’t that he couldn’t find a recalled brand. He couldn’t even find his favorite variety of competitor Tums.

“The shelves were a little bit empty,” said Culp, who lives in Indianapolis. “Instead of Tums, I had to buy generic.”

In less than four months, 18 antacids have been recalled for various reasons.

In the case of Mylanta’s November recall, packaging neglected to note alcohol in its flavoring agents.

Rolaids’ December recall followed consumer reports of foreign materials in the product, including metal and wood particles. Pepcid’s August recall was initiated because of a potential risk of bottles being punctured during the packaging process.

Just last week, Pepcid appealed to customers on its website.

“We apologize for the inconvenience this may be causing you and assure you we are working diligently to get your products back as quickly as possible.”

Marc Boston, a spokesman with McNeil Consumer Healthcare, Johnson & Johnson’s largest consumer unit, said the company has posted openly and honestly about the recalls on each brand website.

At Pepcid, for example, “it not only tells you which products are available but also at which online and local market retailers you can find the products,” he said.

Plenty of people are looking.

A recent study found that 1 in 10 people buys an antacid at least once a month. Sales of antacids nationwide jumped 7% in 2010, pulling in $1.2 billion, according to Drug Store News, a publication on the pharmaceutical industry.

The top three brands in terms of market share: Prilosec OTC, with $288.5 million in sales; Zantac 150, with $72.7 million; and Pepcid Complete, with $53.9 million.

That makes the recalls even more worrisome for brands such as Rolaids and Mylanta, which began losing ground after prescription-only Prilosec and Zantac began offering over-the-counter varieties.

And then there are the store brands, which even before the recalls were taking sales from some of the national brands.

The recall has only bolstered that trend.

“If you’ve got a customer who would normally buy a 20-pack of a brand, and they’ve all been recalled, they are going to buy the store brand,” Meijer spokesman Frank Guglielmi said.

18 antacids involved in recalls

Here are products that have been recalled and how to find out when they will be available.

Rolaids
- Rolaids Extra Strength Softchews, Wild Cherry.
Rolaids Extra Strength Softchews, Cherry.
- Rolaids Extra Strength Plus Gas Softchews, Tropical Fruit.
- Rolaids Multi-Symptom Plus Anti-Gas Softchews, Tropical Fruit.
- Details: Consumer reports of foreign materials in the products, including metal and wood particles, prompted a voluntary recall. McNeil-PPC had determined that the materials were potentially introduced into the product during manufacturing at a third-party facility.
To learn more: www.rolaids.com/page.jhtml?id=rolaids/include/recall_dec.inc

Pepcid
- Pepcid Complete chewable tablets, 50-count Tropical Fruit.
- Original Strength Pepcid AC tablets, 90-count.
- Reason for recall: According to Johnson & Johnson and Merck Consumer Pharmaceuticals, a small number of bottles were punctured during the packaging process, prompting a voluntary recall. This is not a consumer-level recall but is at the wholesaler and retailer levels.
- Details: www.pepcid.com/product-availability; www.pepcid.com/news

Mylanta

- Mylanta Regular Strength Original, 12-ounce.
- Mylanta Original, 5-ounce.
- Mylanta Regular Strength Mint, 12-ounce.
- Mylanta Maximum Strength Cherry, 12-ounce.
- Mylanta Maximum Strength Mint, 12-ounce.
- Mylanta Maximum Strength Original, 12-ounce.
- Mylanta Maximum Strength Original, 24-ounce.
- Mylanta Ultimate Strength Mint, 12-ounce.
- Mylanta Ultimate Strength Cherry, 12-ounce.
- Mylanta Supreme Tasting with Calcium Cherry, 12-ounce.
- Mylanta Supreme Tasting with Calcium Cherry, 24-ounce.
- Alternagel, 12-ounce.
- Reason for recall: After consulting with the FDA, Johnson & Johnson and Merck initiated a recall of 12 Mylanta products after an internal review found that information about the presence of alcohol from flavoring agents (less than 1%) was not noted on the packaging. This is a wholesale- and retail-level recall.
- Details: www.mylanta.com/news.
Source: Company news releases

The Indianapolis Staris a Gannett-owned media company.

McNeil Consumer Healthcare (Canada) Urgently Recalls Various Rolaid Products Sold in Canada

Information Update
2010-220
December 10, 2010
For immediate release

OTTAWA – Health Canada is informing Canadians that McNeil Consumer Healthcare (Canada) is voluntarily recalling all lots of ROLAIDS® Ultra Strength SoftChews® and ROLAIDS® Ultra Strength SoftChews® plus Gas Relief from the Canadian market. McNeil is requesting that wholesalers, pharmacies and other retail locations immediately stop sale of this product.

The company has informed Health Canada that they are taking this action following consumer reports of foreign materials in the product, including metal and wood particles. The company is advising consumers who have purchased these recalled products to discontinue use.

Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioner or contact McNeil Consumer Healthcare by calling the Johnson & Johnson Inc. Consumer Contact Centre at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). For more information, please visit Next link will take you to another Web site the company’s website (PDF Version – 119 K).

Health Canada will continue to monitor the safety of health products on the Canadian market, including those manufactured at McNeil Consumer Healthcare plants and will inform Canadians if new safety information arises. Health Canada will take appropriate action to help protect the health and safety of Canadians should further risks to health be identified.

Product Recall Information

All lot numbers and all flavors of ROLAIDS® SoftChews® are affected by this recall.

Description DIN
ROLAIDS® Ultra Strength SoftChews® Plus Gas Relief Tropical Fruit 36′s DIN 02269171
ROLAIDS® Ultra Strength SoftChews® Plus Gas Relief Tropical Fruit 24′s DIN 02269171
ROLAIDS® Ultra Strength SoftChews® Cherry 6′s NPN 02247315
ROLAIDS® Ultra Strength SoftChews® Vanilla 6′s NPN 02247315
ROLAIDS® Ultra Strength SoftChews® Cherry 42′s NPN 02247315
ROLAIDS® Ultra Strength SoftChews® Cherry 36′s NPN 02247315
ROLAIDS® Ultra Strength SoftChews® Vanilla 42′s NPN 02247315
ROLAIDS® Ultra Strength SoftChews® Vanilla 36′s NPN 02247315

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

  • Fax: 1-866-678-6789
  • Internet: www.healthcanada.gc.ca/medeffect
  • Mail: Canada Vigilance Program
    Marketed Health Products Directorate
    Ottawa, ON, Address Locator 0701E
    K1A 0K9

Recalls Issued For Children’s Benadryl, Motrin & Rolaids Softchews

Johnson & Johnson continues to earn its title as the recall king of the over-the-counter drug business with the announcement of three separate recalls totaling around 5 million units of Children’s Benadryl Allergy Fastmelt Tablets, Junior Strength Motrin Caplets, and Extra Strength Rolaids Softchews.

Without giving a specific reason for the recall J&J’s McNeil Laboratories division has initiated a voluntary recall of all product lots of Children’s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength Motrin Caplets, 24 count, that were distributed in the United States.

From the company’s recall sites for the Benadryl and Motrin recalls:

This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil’s Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.

Meanwhile, the Rolaids recalls is both slightly more specific and significantly smaller than the other two.

McNeil is only recalling one product lot of the Extra Strength Softchews, Cherry Flavor, 36 count package, that was distributed in the United States.

“The recall was initiated as a precaution following consumer complaints of an uncharacteristic consistency or texture, traced to crystallized sugar in the product,” reads a statement on the recall site. But like the other recalls, the company says there is no reason for customers to stop using the product.

The recalled number is 0053AG2, which can be found on the back of the Rolaids Extra Strength Softchews, Cherry Flavor, 36 count package.

If you have questions, you can contact the company’s Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)

Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall – Foreign Materials in Products

From the FDA Website:

[Posted 12/14/2010]

AUDIENCE: Consumer

ISSUE: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. recalled all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the United States, following consumer reports of foreign materials in the product, including metal and wood particles.

BACKGROUND: The company’s investigation determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the investigation is ongoing, production of these products has been suspended and will not restart until corrective actions have been implemented.

RECOMMENDATION: Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com disclaimer icon or by calling 1-888-222-6036 for instructions about receiving a refund. Consumers who have medical concerns or questions should contact their healthcare provider.

Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/09/2010 – Press Release – McNeil Consumer Healthcar

Tylenol, Benadryl, Sudafed, Sinutab and Rolaids Recall

A new year has begun, but the product recalls continue at McNeil Consumer Healthcare, a troubled unit of Johnson & Johnson.

Tylenol is being recalled. Again.

Rolaids are being recalled. Also Again. We reported on the December recall in Antacid Alert: Rolaids Recall

McNeil is voluntarily recalling Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol upper respiratory products, as well as Benadryl, Sudafed PE, and Sinutab products distributed in the U.S., the Caribbean, and Brazil. In addition, some Rolaids products are again being recalled.

These problems bring to mind an article that appeared in Fortune magazine in August: Why J&J’s headache won’t go away.

According to Fortune, Johnson & Johnson, the iconic maker of Band-Aids, has come under scrutiny from the U.S. Food and Drug Administration (FDA) as well as the U.S. Congress for a series of quality-control problems.

So you can find out about the details of the recall, including links to more information, we have included the release from the manufacturer below:

McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products

 

Fort Washington, PA (January 14, 2011) – In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended. The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.
McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.

Both of these recalls are being initiated at the wholesale level. No action is required by consumers or healthcare providers and consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events.

McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products. As previously announced, McNeil has been implementing a Comprehensive Action Plan at its U.S. manufacturing facilities to improve the quality systems at those sites. This product assessment is a key milestone in the implementation of that plan, and the actions being undertaken as a result of the assessment are part of McNeil’s ongoing commitment to ensure that all its products meet the high quality standards that consumers expect.

Consumers can access full product details and other information about the recall on the www.mcneilproductrecall.com website or by calling our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

Any adverse reactions may also 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, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Click Here for recall information on certain product lots of recalled products
Click Here to see frequently asked questions

Sources:

McNeil Consumer Healthcare