FDA Drug Class II — Moderate

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

Hazard

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

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 ---
Brand
The Harvard Drug Group
UPC
Item # 370339, all lots

Units Affected

4,715 bottles