D-1441-2016 Class III Terminated
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