D-1122-2017 Class II Terminated
FDA drug recall D-1122-2017 was initiated by The Harvard Drug Group on August 2, 2017 and is designated Class II. Reason for recall: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination The recall status is terminated (terminated July 16, 2024). Affected quantity: 4,715 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 30, 2017
- Initiation Date
- August 2, 2017
- Termination Date
- July 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,715 bottles
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
Distribution Pattern
Nationwide in the USA
Code Information
Item # 370339, all lots