Rugby Aller-chlor recall: Sterility Concern
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
Why was Rugby Aller-chlor recalled?
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item # 370339, all lots
- Product
- 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
- Recalling firm
- The Harvard Drug Group
- Quantity
- 4,715 bottles
- Distribution
- Nationwide in the USA
- Recall date
- August 30, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)