PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 27, 2019 Initiated: January 16, 2019 #D-1007-2019

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.

Details

Units Affected
29,622 Blister Cards
Distribution
Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by Rx Pak Division of McKesson Corporation. Units affected: 29,622 Blister Cards.
Why was this product recalled?
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1007-2019.