The FDA issued a new warning this weekend involving more children’s cold medicine.
This time the agency is asking parents not to use four PediaCare medicines. All were made at the McNeil Consumer Healthcare plant in Pennsylvania which has been shut down since another recall involving children’s medicines last month.
The four PediaCare items involved in this most recent recall are:
- PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
- PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
- PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
- PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4
Blacksmith Brands initiated the recall as a precautionary step. No complaints have been received about the safety or purity of the products.
While the recall was not initiated as a result of either any consumer reports of adverse events or complaints with respect to the PediaCare products, tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant.
If you bought any of these products you should call Blacksmith Brands on Saturday-Monday 9am-5pm EST; and normal business hours thereafter at (888) 474-3099. More information is available at blacksmithbrands.com.
Any adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. or on the Med watch website at http:www.fda.gov/safety/medwatch/default.htm
This recall is happening at a time when the FDA is already scrutinizing McNeil. Last week a congressional investigators reported that there had been problems at this plant dating back to 2008 and that instead of issuing a recall the company hired an outside contractor to buy up the products.
I remember getting calls from parents asking why they couldn't find these items on store shelves in April and when I called to ask about it, I was told it was a simple supply issue.
The FDA has put together a web site to answer some of the most common questions parents have here.