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

FDA recall notice · announced July 20, 2016 · West-ward Columbus

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide
Lot/code information: Lot #560185A; Exp. 6/30/2017
Quantity: 1,182 bottles
Status: Terminated
Products in this recall event:
- Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41 (D-1441-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.