FDA recall D-1135-2017

Product

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.

Reason for recall

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Distribution

TX

Key facts

Status

Terminated

Initiation date

2017-08-30

Report date

2017-09-20

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raymondville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2017