FDA recall D-0386-2021

KVK-Tech, Inc. · Class III · drug

Product

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-04-27
Report date: 2021-05-26
Termination date: 2022-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2021