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Recall Observatory FDA recall evidence

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

D-0233-2017

November 18, 2016

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 75757
Status
Terminated
Classification
Class II
Quantity
22,704 bottles
Official record key
drug-enforcement:D-0233-2017

Official wording

Reason: CGMP Deviations

Code information: Lot # 35254; Exp. 05/20

Distribution pattern: NY

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations