January 2018 FDA Recall Oxycodone Hydrochloride by Ascent Pharmaceuticals, Inc.
D-0248-2018 - Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
This Class III drug recall was voluntarily initiated by Ascent Pharmaceuticals, Inc. on January 22, 2018 for the product Oxycodone Hydrochloride. The FDA reported the reason for recall as labeling; label error not elsewhere classified; label missing controlled substance cii symbol. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0248-2018
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
01-22-2018
02-07-2018
45,875 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascent Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-23-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
