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

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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

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.fda.gov/MedWatch/report
• 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.

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574257.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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