Recall: D-0386-2021

Class III - Minor Violations

Class IIIClassification

2021-04-27Initiated

TerminatedStatus

KVK-Tech, Inc.Firm

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

Failed Impurities/Degradation Specifications

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.