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Recall Observatory FDA recall evidence

Drug product

Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy

D-0293-2017

November 17, 2016

Class II

Product summary

Firm
Tri-Coast Pharmacy
Event
Event 75763
Status
Ongoing
Classification
Class II
Quantity
2116 vials
Official record key
drug-enforcement:D-0293-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016B (11/21/2016), 06232016B (12/20/2016), 07152016B (01/11/2017), 08262016D (01/30/2017), 08152016A (01/30/2017), 08022016C (01/29/2017), 09282016C (03/27/2017), 10192016C (04/17/2016), 10252016B (04/23/2017).

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility