Kids' Relief Ear Relief Oral Liquid 3025 de'l Assomption Blvd recalled over manufacturing violations
- Recall date
- November 18, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Raritan Pharmaceuticals, Inc. recalls Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 6051…
- Recall number
- D-0233-2017
- FDA classification
- Class II
- Brand / firm
- Raritan Pharmaceuticals, Inc.
- Sold / distributed
- NY
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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