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, Manufactured by PharmaTech LLC, Davie FL

Reported: January 24, 2018 Initiated: August 16, 2017 #D-0227-2018

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, Manufactured by PharmaTech LLC, Davie FL

Reason for Recall

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

Details

Recalling Firm
Pharmatech LLC
Units Affected
Unknown
Distribution
MI
Location
Davie, FL

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, Manufactured by PharmaTech LLC, Davie FL. Recalled by Pharmatech LLC. Units affected: Unknown.
Why was this product recalled?
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Which agency issued this recall?
This recall was issued by the FDA Drug on January 24, 2018. Severity: Moderate. Recall number: D-0227-2018.