Recalls / Class II
Class IID-1121-2017
Product
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
- Affected lot / code info
- Item # 263923, all lots
Why it was recalled
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 26,891 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-08-02
- FDA classified
- 2017-08-24
- Posted by FDA
- 2017-08-30
- Terminated
- 2024-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1121-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.