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

Recall Number: D-0386-2021

Firm: KVK-Tech, Inc.

Classification: Class III

Status: Terminated

Report Date: 20210526

Initiation Date: 20210427

Termination Date: 20221005

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

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