Product: Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16
Reason for recall: Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Recall initiated: 20191101
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated