FDA recall D-0276-2022

Ascent Pharmaceuticals, Inc. · Class II · drug

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.

Reason for recall

Product Mix-up

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2021-11-19
Report date
2021-12-15
Termination date
2023-12-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2022