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Recall Observatory FDA recall evidence

Drug product

Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

D-0450-2019

December 17, 2018

Class II

Product summary

Firm
Promise Pharmacy, LLC
Event
Event 81810
Status
Terminated
Classification
Class II
Quantity
341 vials
Official record key
drug-enforcement:D-0450-2019

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 07102018@3 BUD: 1/6/2019 08302018@9 BUD: 2/26/2019

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility