Problems at McNeil Consumer Healthcare's Fort Washington, Pa., facility have led to another recall of children's medications.
Blacksmith Brands Inc. announced May 28 that it is voluntarily recalling all lots of four products in its PediaCare line. The company said in a news release(www.fda.gov) that it is recalling the OTC products as a precautionary measure because they were manufactured for Blacksmith by McNeil Consumer Healthcare at McNeil's Fort Washington plant.
McNeil closed that facility after the FDA issued a highly critical report(www.fda.gov) on April 30 that said the plant did not meet the agency's good manufacturing practices requirements.
That same day, McNeil announced(www.fda.gov) it was recalling all unexpired lots of certain brand-name OTC children's and infants' liquid medications -- including more than 40 variations of Tylenol, Motrin, Zyrtec and Benadryl products -- because of manufacturing deficiencies at the Fort Washington facility.
Blacksmith said in its release that it had not received any consumer complaints or reports of adverse events associated with the PediaCare products. However, the company said that although the potential for serious adverse events is remote, consumers who have purchased the recalled PediaCare products are advised to discontinue their use.
The four PediaCare items involved in the recall are
- PediaCare Multi-Symptom Cold,
- PediaCare Long-Acting Cough,
- PediaCare Decongestant and
- PediaCare Allergy & Cold.
PediaCare Allergy, PediaCare Gentle Vapors Vapor-Plug Unit & Nightlight, and PediaCare Gentle Vapors refills were not produced at McNeil's Fort Washington facility and are not included in the recall, Blacksmith said.
Blacksmith said it plans to shift production of the recalled products to other manufacturing plants and expects to resume shipping in July.
Consumers with questions about the recalled products may contact Blacksmith at (888) 474-3099. Adverse events associated with the use of these products should be reported to the FDA's MedWatch Program(www.fda.gov).