November 2021 FDA Recall Hydrocodone Bitartrate And Acetaminophen by Ascent Pharmaceuticals, Inc.
D-0276-2022 - Product Mix-up
This Class II drug recall was voluntarily initiated by Ascent Pharmaceuticals, Inc. on November 19, 2021 for the product Hydrocodone Bitartrate And Acetaminophen. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0276-2022
Product Mix-up
11-19-2021
12-15-2021
9744 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
USA Nationwide
12-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
Batch or Lot Expiration Information
Lot# : 21070817, Exp 6/2023
