Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.
Recall Number: D-1135-2017
Firm: Mid Valley Pharmaceutical
Classification: Class II
Status: Terminated
Report Date: 20170920
Initiation Date: 20170830
Termination Date: 20200507
Reason for Recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Product Description
Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.