Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactu...
FDA Recall #D-160-2013 — Class II — November 20, 2012
Product Description
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
Reason for Recall
Failed Dissolution Test Requirements
Recalling Firm
Upsher Smith Laboratories, Inc. — Maple Grove, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
60 bottles
Distribution
FL, NJ.
Code Information
Lot #308198, Expiration Date is 03/2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated