Drug product
Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
D-1007-2019
Product summary
- Event
- Event 81943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,622 Blister Cards
- Official record key
drug-enforcement:D-1007-2019
Official wording
Reason: Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Code information: Lot # 0119397, Exp 02/2020
Distribution pattern: Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up