Recalls / Class III
Class IIID-0248-2018
Product
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
- Brand name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 31722-484, 31722-485, 31722-917, 31722-486, 31722-918
- FDA application
- ANDA207418
- Affected lot / code info
- Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
Why it was recalled
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Recalling firm
- Firm
- Ascent Pharmaceuticals, Inc.
- Manufacturer
- Camber Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 550 S Research Pl, Central Islip, New York 11722-4415
Distribution
- Quantity
- 45,875 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-01-22
- FDA classified
- 2018-02-01
- Posted by FDA
- 2018-02-07
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0248-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.