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.