D-1441-2016 Class III Terminated

Recalled by West-Ward Columbus Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
July 20, 2016
Initiation Date
May 19, 2016
Termination Date
February 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,182 bottles

Product Description

Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41

Reason for Recall

Failed Impurities/Degradation Specification; 9 month stability

Distribution Pattern

Nationwide

Code Information

Lot #560185A; Exp. 6/30/2017