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Recall: Potential B. Cepacia Contamination in Mid Valley Cough Syrup

By FDA | August 31, 2017

Mid Valley Pharmaceutical LLC issues voluntary recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief syrup due to potential contamination with Burkholderia cepacia.

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.

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.  The following lots are being recalled:

Product Bottle Size UPC Lot # Expiration
Doctor Manzanilla Allergy & Decongestant Relief 4 FL OZ. (118 ml) 7 62558 00204 1 23221701 05/19
Doctor Manzanilla Cough & Cold 4 FL OZ. (118 ml) 7 62558 00316 1 23221701 05/19

Mid Valley Pharmaceutical is notifying its distributors by email and is arranging for return of all recalled products.  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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

(Source: FDA)

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