November 2012 FDA Recall Drug by Upsher Smith Laboratories, Inc.
D-160-2013 - Failed Dissolution Test Requirements
This Class II drug recall was voluntarily initiated by Upsher Smith Laboratories, Inc. on November 20, 2012 for the product Drug. The FDA reported the reason for recall as failed dissolution test requirements. The product was distributed in FL, NJ. and the recall is currently terminated.
Recall Number: D-160-2013
Failed Dissolution Test Requirements
11-20-2012
02-20-2013
60 bottles
Recall Profile & Regulatory Data
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.
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.
Upsher Smith Laboratories, Inc.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
FL, NJ.
07-12-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
Batch or Lot Expiration Information
Lot# 308198, Expiration Date is 03/2014
