Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

spacer.gif (43 bytes)

FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

7 Different Pedia Care Over-the-Counter Infant Medications Recalled

PRODUCT
Pediacare brand OTC products for pediatric use.  Labels for the first five products listed may state either McNeil Consumer Products Company Division of McNeil-PPC, Inc, or Marketed by Pharmacia & Upjohn Consumer Healthcare. 

The labels for the last two products listed state Marketed by Pharmacia & Upjohn Consumer Healthcare:

a) Pedia Care Cough-Cold liquid (Each 5 mL contains pseudoephedrine hydrochloride
   15 mg, chlorpheniramine maleate 1 mg, and dextromethorphan hydrobromide 5 mg),
   in 4 fluid ounce bottles;
b) Pedia Care Cough-Cold Chewables (Each tablets contains pseudoephedrine
   hydrochloride 15 mg, chlorpheniramine maleate 1 mg, and dextromethorphan
   hydrobromide 5 mg), 16 tablets;
c) Pedia Care NightRest Cough-Cold liquid (Each 5 mL contains pseudoephedrine
   hydrochloride 15 mg, chlorpheniramine maleate 1 mg, and dextromethorphan
   hydrobromide 7.5 mg), in 4 fluid ounce bottles;
d) Pedia Care Infants' Drops Decongestant (Each 0.8mL (dropperful) contains
   pseudoephedrine hydrochloride 7.5 mg), in 1/2 fluid ounce (15mL) bottles;
e) Pedia Care Infants' Drops Decongestant Plus Cough (Each 0.8mL (dropperful)
   contains pseudoephedrine hydrochloride 7.5 mg and dextromethorphan
   hydrobromide 2.5 mg)), in 1/2 fluid ounce (15mL) bottles;
f) Pedia Care Fever liquid , Ibuprofen Oral Suspension, 100 mg per 5 mL (teaspoon),
   in 4 fluid ounce bottles;
g) Pedia Care Fever drops, Ibuprofen Oral Suspension, 50 mg per 1.25 mL
   (dropperful), in 1/2 fluid ounce bottles.
Recall #D-158/164-9.

CODE
All lots at retail with coupons attached.

MANUFACTURER
Pharmacia & Upjohn, Kalamazoo, Michigan.

RECALLED BY
Manufacturer, by letter dated February 9, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
419,000 packages were distributed.

REASON
Mislabeling - Some units are overlabeled with an incorrect peel off coupon.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.