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Recall Observatory FDA recall evidence

Drug product

Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy

D-0292-2017

November 17, 2016

Class II

Product summary

Firm
Tri-Coast Pharmacy
Event
Event 75763
Status
Ongoing
Classification
Class II
Quantity
441 vials
Official record key
drug-enforcement:D-0292-2017

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): 05252016C (11/21/2016), 07252016B (01/21/2017), 09192016B (03/18/2016).

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility