Drug product
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
D-0377-2022
Product summary
- Firm
- Lohxa, LLC
- Event
- Event 89272
- Status
- Terminated
- Classification
- Class I
- Quantity
- 87,840 unit dose cups
- Official record key
drug-enforcement:D-0377-2022
Official wording
Reason: Microbial Contamination of Non-Sterile Product
Code information: Lot #: AM1115S, Exp. Date 01/2023
Distribution pattern: Product was distributed to one wholesale who further distributed the product nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination