PediaCare Children's Allergy & Cold FDA Alerts

The FDA Alert(s) below may be specifically about PediaCare Children's Allergy & Cold or relate to a group or class of drugs which include PediaCare Children's Allergy & Cold (diphenhydramine/phenylephrine).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for diphenhydramine/phenylephrine

Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia

Aug 30, 2017

Audience: Consumers, Pharmacy

ISSUE: Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.

BACKGROUND: Doctor Manzanilla Cough & Cold is sold over the counter for relief of cough, nasal decongestion, throat irritation, sneezing, itching watery eyes, and bronchial irritation. Doctor Manzanilla Allergy & Decongestant Relief is sold over the counter for relief of allergy, nasal decongestion, itchy throat, sneezing, itchy watery eyes, and as an antihistamine. Product was distributed locally in the Rio Grande Valley, Texas to retailers and pharmacies.

RECOMMENDATION: Consumers/distributors/retailers that have Doctor Manzanilla products which are being recalled should stop using/selling/distributing and return product to the place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product and are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[08/30/2017- Recall - Mid Valley Pharmaceutical]

PediaCare Children's Products [Blacksmith Brand]: Recall of four products

May 29, 2010

Audience: Consumers, Pediatrics healthcare professionals

Blacksmith Brands and FDA notified healthcare professionals and patients about a nationwide recall of all lots of four PediaCare children's products. These products are sold exclusively in the United States and were manufactured by McNeil Consumer Healthcare at McNeil's Fort Washington, PA plant.

The four PediaCare items involved in the 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 because the products were manufactured at a McNeil plant in which a recent FDA inspection found serious problems in meeting FDA's current good manufacturing practice requirements. The company advises consumers who have purchased these recalled products to discontinue use.

[05/28/2010 - Press Release - Blacksmith Brands]