FDAClass IIJanuary 4, 2017

Kids' Relief Ear Relief Oral Liquid recall: CGMP Deviations

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

Why was Kids' Relief Ear Relief Oral Liquid recalled?

CGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 35254; Exp. 05/20

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
Recalling firm
Raritan Pharmaceuticals, Inc.
Quantity
22,704 bottles
Distribution
NY
Recall date
January 4, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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