FDA recall D-0248-2018

Ascent Pharmaceuticals, Inc. · Class III · drug

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

Reason for recall

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-01-22
Report date
2018-02-07
Termination date
2018-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2018