FDA recall D-0233-2017

Raritan Pharmaceuticals, Inc. · Class II · drug

Product

Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639

Reason for recall

CGMP Deviations

Distribution

NY

Key facts

Status
Terminated
Initiation date
2016-11-18
Report date
2017-01-04
Termination date
2020-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2017