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Mid Valley Pharmaceutical recalls two drugs.
Two regional brands of OTC cough, cold, and allergy products are being recalled due to contamination with the bacteria Burkholderia cepacia.
Mid Valley Pharmaceutical has recalled lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. Both products are distributed in the Rio Grande Valley region of Texas and are sold by pharmacies and other retail outlets.
B. cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. This is the same bacteria that has led to recent recalls of several brands of drugs and dietary supplements manufactured by PharmaTech.
According to the CDC, B. cepacia is an environmental pathogen that can live on surfaces and in water. B. cepacia complex bacteria can exhibit resistance to preservatives, and can cause contamination of liquid medications or other liquid products.
There have been no reports of adverse events related to this recall, according to Mid Valley Pharmaceutical.
Consumers, distributors, and retailers that have Doctor Manzanilla products affected by the recall should stop using, selling, or distributing the products and return them 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 online at www.fda.gov/MedWatch/report 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.