PlainRecalls
FDA Drug Moderate Class II Terminated

Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.

Reported: October 5, 2016 Initiated: August 8, 2016 #D-1526-2016

Product Description

Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.

Reason for Recall

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Details

Recalling Firm
Pharmatech LLC
Units Affected
68,908 bottles
Distribution
Nationwide
Location
Davie, FL

Frequently Asked Questions

What product was recalled?
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.. Recalled by Pharmatech LLC. Units affected: 68,908 bottles.
Why was this product recalled?
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 5, 2016. Severity: Moderate. Recall number: D-1526-2016.