FDA-Drug2016-07-20Class III

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

West-Ward Columbus Inc
Hazard

Failed Impurities/Degradation Specification; 9 month stability

Sold states
Nationwide
Affected count
1,182 bottles
Manufactured in
1809 Wilson Rd, Columbus, OH, United States
Products
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1441-2016

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