FDA-Drug2017-08-30Class II

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

The Harvard Drug Group
Hazard

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

Sold states
Nationwide in the USA
Affected count
4,715 bottles
Manufactured in
17177 N Laurel Park Dr Ste 233, Livonia, MI, United States
Products
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

Official notice

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

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