FDA recall D-1520-2016

Pharmatech LLC · Class II · drug

Product

Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-08-08
Report date
2016-10-05
Termination date
2024-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1520-2016