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.
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