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.
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