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Recall Observatory FDA recall evidence

Drug product

MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28

D-0483-2017

January 27, 2017

Class II

Product summary

Firm
Cherry Hill Sales Co.
Event
Event 76407
Status
Terminated
Classification
Class II
Quantity
3,600 cartons
Official record key
drug-enforcement:D-0483-2017

Official wording

Reason: CGMP Deviations

Code information: Lot #103811; Exp. 09/17 Lot #105304; Exp. 04/18 NDC 69020-205-28 UPC 857181005108

Distribution pattern: Michigan, Illinois, New York, Florida, Pennsylvania .

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations