Drug product
GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087
D-0848-2018
Product summary
- Event
- Event 80053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21213 bottles
- Official record key
drug-enforcement:D-0848-2018
Official wording
Reason: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Code information: Lot #: 47070082, 47070043, 47070011, Exp. 09/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification