FDA recall D-0532-2020

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-11-01

Report date

2019-11-20

Termination date

2020-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0532-2020