Drug product
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.
D-1526-2016
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 74874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68,908 bottles
- Official record key
drug-enforcement:D-1526-2016
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 #: 20391517, Exp 09/17; 20391518, Exp10/17; 20391519, Exp 11/17; 20391601, Exp 01/18; 20391602, Exp 02/18; 20391604, 20391605, Exp 03/18; 20391608, Exp 06/18
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations