Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Ma...

FDA Recall #D-0276-2022 — Class II — November 19, 2021

Recall #D-0276-2022 Date: November 19, 2021 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

Product Mix-up

Recalling Firm

Ascent Pharmaceuticals, Inc. — Central Islip, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

9744 bottles

Distribution

USA Nationwide

Code Information

Lot #: 21070817, Exp 6/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated