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Recall Observatory FDA recall evidence

Drug product

SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-997-2013

July 26, 2013

Class II

Product summary

Firm
Beacon Hill Medical Pharmacy, P.C.
Event
Event 65876
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-997-2013

Official wording

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information: 03182013@6, 03282013@26,01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, 03182013@14

Distribution pattern: USA nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility