Drug product
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
D-0850-2018
Product summary
- Event
- Event 80053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31411 bottles
- Official record key
drug-enforcement:D-0850-2018
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 #: 47060011, 47070031, 47070041, Exp. 09/18; 47080031, Exp.10/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification