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

FDA recall notice · announced March 27, 2019 · Rx Pak Division Of Mckesson

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
Lot/code information: Lot # 0119397, Exp 02/2020
Quantity: 29,622 Blister Cards
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.