Drug product
Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08
D-1437-2019
Product summary
- Firm
- Geritrex, LLC
- Event
- Event 82947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24312 units
- Official record key
drug-enforcement:D-1437-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Code information: Lot #: 1806031, 1806014, Exp. 08/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications