PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 30, 2017 Initiated: August 2, 2017 #D-1122-2017

Product Description

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

Details

Recalling Firm
The Harvard Drug Group
Units Affected
4,715 bottles
Distribution
Nationwide in the USA
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by The Harvard Drug Group. Units affected: 4,715 bottles.
Why was this product recalled?
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2017. Severity: Moderate. Recall number: D-1122-2017.