FDA recall D-0227-2018

Product

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL

Reason for recall

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

Distribution

MI

Key facts

Status

Terminated

Initiation date

2017-08-16

Report date

2018-01-24

Termination date

2023-01-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2018