FDA recall D-1122-2017

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

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-08-02

Report date

2017-08-30

Termination date

2024-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1122-2017