Drug product
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
D-0342-2018
Product summary
- Event
- Event 78952
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,400 bottles
- Official record key
drug-enforcement:D-0342-2018
Official wording
Reason: Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Code information: Lot # 352300, Exp 01/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up