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Recall Observatory FDA recall evidence

Drug product

CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639

D-0234-2017

November 18, 2016

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 75757
Status
Terminated
Classification
Class II
Quantity
20,448 bottles
Official record key
drug-enforcement:D-0234-2017

Official wording

Reason: CGMP Deviations

Code information: Lot # 33149; Exp. 01/20

Distribution pattern: NY

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations