Recalls / Class III
Class IIID-1441-2016
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
- Brand name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDC
- 0054-0390
- FDA application
- ANDA204037
- Affected lot / code info
- Lot #560185A; Exp. 6/30/2017
Why it was recalled
Failed Impurities/Degradation Specification; 9 month stability
Recalling firm
- Firm
- West-Ward Columbus Inc
- Manufacturer
- Hikma Pharmceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 1,182 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-19
- FDA classified
- 2016-07-14
- Posted by FDA
- 2016-07-20
- Terminated
- 2017-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1441-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.