A recall of four PediaCare children’s medications happened just before the long holiday weekend.
The Food and Drug Administration (FDA), working with Blacksmith Brands Inc., issued the voluntary recall for the over-the-counter pediatric medicines because they were produced at the same problematic Pennsylvania plant that made the recently recalled Children’s Tylenol made by McNeil Consumer Healthcare.
The Fort Washington, Pa. plant was closed after FDA inspectors found it was filthy, had a hole in the ceiling and inconsistent formulations including some that were “super potent” with acetaminophen.
While stressing the recall was not based on any adverse health reports, Blacksmith says on its Web site that "tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant."
Blacksmith says it initiated the recall in an abundance of caution.
Among the products recalled are:
1. PediaCare Multi-Symptom Cold 4oz. UPC #30045-0556-059
2. PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-047
3. PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
4. PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04
The numbers of the product are found on the label above the brand name. Expiration dates and lot numbers are found on the back or side of the label on the bottle.
Expect to see the product back on store shelves when Blacksmith Brands finds another manufacturing plant.
Consumers are urged to stop using the recalled products but not to empty them down the sink or toilet. Contact your local pharmacy to determine what you state requires for unused drug disposal.
Smarxtdisposal.net tells consumers how to properly dispose of medications.
The company also produces Efferdent and Effergrip denture products and Luden’s throat drops and NasalCrom.
Blacksmith adds that the following products are not involved in the recall:
* PediaCare Allergy 4oz.
* PediaCare Gentle Vapors Plug in Units
* PediaCare Gentle Vapors refills
Johnson & Johnson/ McNeil Investigation Continues
The Committee on Oversight and Government Reform is investigating the Blacksmith/ Johnson and Johnson /McNeil recalls. Chairman, Edolphus “Ed” Towns (D-NY) in a statement says, “We cannot take any recalls at this plant lightly,” said Chairman Towns. “Nothing is more important than the health and welfare of our children and as I have said before, we will continue to ask tough questions about these incidents.”
Rep. Towns has written a letter to the chair of Blacksmith Brands asking him for company documents related to the May 28 recall of PediaCare and documents on any adverse reactions to or knowledge of contamination of the medication.
The committee is already investigating the recall of popular over-the-counter pediatric medications, Tylenol, Motrin, Benadryl and Zyrtec. More than 130 million bottles of over-the-counter medication has been recalled.
As the investigation into the McNeil Healthcare's (a subsidiary of Johnson and Johnson) manufacturing lapses, the FDA announced before the holiday it is considering criminal penalties, product seizures, or other sanctions, reports the New York Times.
Particularly troubling are reports that McNeil hired a contractor to conduct a “phantom” recall of Motrin products from retailers without calling it a recall.
“I have become deeply concerned about your company,” Rep. Towns told a Johnson & Johnson executive who testified May 27. “It paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk.” #