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.
D-1520-2016
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 74874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,008 bottles
- Official record key
drug-enforcement:D-1520-2016
Official wording
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot #: 20391519, Exp 11/17
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations