FDA recall D-1007-2019

Rx Pak Division of McKesson Corporation · Class II · 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

Reason for recall

Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.

Distribution

Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.

Key facts

Status: Terminated
Initiation date: 2019-01-16
Report date: 2019-03-27
Termination date: 2020-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1007-2019