Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Man...
FDA Recall #D-0097-2021 — Class II — October 26, 2020
Product Description
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01
Reason for Recall
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
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
9768 Bottles
Distribution
Nationwide within the United States
Code Information
Lot #: 20070518, Exp. Date June 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated