Recall: D-0532-2020

Class II - Potentially Harmful

Class IIClassification

2019-11-01Initiated

TerminatedStatus

KVK-Tech, Inc.Firm

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

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Distribution

Nationwide within the United States

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