October 2015 FDA Recall Donnatal by Rx Pak
D-0053-2016 - Labeling
This Class III drug recall was voluntarily initiated by Rx Pak on October 13, 2015 for the product Donnatal. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0053-2016
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
10-13-2015
10-28-2015
2530 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Rx PAK
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-30-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
Batch or Lot Expiration Information
Lot# : 107934 Exp 9/16, 108060 Exp 5/16
