D-1007-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- January 16, 2019
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,622 Blister Cards
Product Description
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
Reason for Recall
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Distribution Pattern
Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
Code Information
Lot # 0119397, Exp 02/2020