FDA recall D-0097-2021

Product

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.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-10-26

Report date

2020-11-25

Termination date

2023-02-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2021