D-1121-2017 Class II Terminated
FDA drug recall D-1121-2017 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: 26,891 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
- 26,891 bottles
Product Description
Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09
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 # 263923, all lots