Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC ...

FDA Recall #D-0233-2017 — Class II — November 18, 2016

Recall #D-0233-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

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

Recalling Firm

Raritan Pharmaceuticals, Inc. — East Brunswick, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

22,704 bottles

Distribution

NY

Code Information

Lot # 35254; Exp. 05/20

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated