On May 28, 2010, Blacksmith Brands Inc. issued a voluntary recall of four of its over-the-counter PediaCare medications because they were manufactured in the same plant as other children's medicines that the Food and Drug Administration labeled potentially harmful.
Products Affected by the Recall
The New-York-based company issued the statement just before the Memorial Day weekend, and many consumers remain unaware of the recall. The PediaCare products that have been recalled are:
- PediaCare Multi-Symptom Cold, 4 oz
- PediaCare Long Acting Cough, 4oz
- PediaCare Decongestant, 4oz
- PediaCare Allergy and Cold, 4oz
PediaCare products that are not included in the recall are:
- PediaCare Allergy, 4oz
- PediaCare Gentle Vapors Plug In Units and Refills
Reasons for the Voluntary Recall
Blacksmith Brands issued the recall in response to the recent closing of the manufacturing plant in Fort Washington, Pennsylvania, where the medicines were produced. The plant was owned by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, and was shut down by the FDA due to problems ranging from unsanitary conditions to contamination of formulas with metal particles and excessive amounts of acetaminophen.
The Committee on Oversight and Government Reform has been investigating McNeil since the plant was shut down on April 30 and the company issued a massive recall of the products manufactured there. The McNeil products involved in the recall account for nearly 70% of available over-the-counter pediatric medicines, including Children's Tylenol, Motrin, Benadryl and Zyrtec.
Plant Owners May Have Tried to Conceal Problems
Investigators have also found evidence that McNeil hired a private contractor in 2008 to quietly remove its products from retailers instead of informing the FDA about defective products and issuing a public recall. Investigators are asking Blacksmith Brands to hand over all contracts and communication with McNeil.
No Reported Illnesses from PediaCare Products
The Blacksmith Brands website reminds consumers that there have been no reports of harmful side effects of their products, and that the recall was preemptive and due only to the shared manufacturing site with McNeil products.
Blacksmith Chairman and CEO Peter Mann stated, "Protecting consumers and maintaining their trust are essential to our company's core values."
The company recommends that consumers discontinue use of the recalled products and contact their local pharmacies for state-specific regulations on how to dispose of unused medicine.
