FDAFDA · Food and drugs·Recall number D-1007-2019
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
Published March 27, 2019 · Recall initiated: January 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Rx Pak Division of McKesson Corporation
- Distributor
- Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
- Lot
- Lot # 0119397, Exp 02/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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