January 2019 FDA Recall Drug by Rx Pak Division Of Mckesson Corporation
D-1007-2019 - Labeling

This Class II drug recall was voluntarily initiated by Rx Pak Division Of Mckesson Corporation on January 16, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed to 5 major distributors who may have further distributed the product throughout the United States. and the recall is currently terminated.

Recall Number: D-1007-2019

Reason for Recall
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Initiated
01-16-2019
Reported
03-27-2019
Quantity
29,622 Blister Cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81943
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Rx Pak Division of McKesson Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2020
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# 0119397, Exp 02/2020