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U.S. Department of Health and Human Services

Safety

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Perrigo Infants' Oral Drops Containing Enclosed Syringe

Audience: Pharmacists, Pediatricians and other healthcare professionals

[Posted 08/02/2005] Perrigo and FDA notified healthcare professionals and consumers of the recall of all lots of concentrated infants’ drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing:

1. acetaminophen,
2. acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or
3. dextromethorphan HBr, and pseudoephedrine HCl.

The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. The following products are being recalled:

  • Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
  • Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
  • Cherry Flavor Cough and Cold Infant Drops (0.5oz)
  • Cherry Flavor Decongestant and Cough Infant Drops (0.5oz)

[July 29, 2005 - Press Release - Perrigo]