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Recall Observatory FDA recall evidence

Drug product

Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

D-0394-2017

September 21, 2016

Class II

Product summary

Firm
Wells Pharmacy Network LLC
Event
Event 75289
Status
Terminated
Classification
Class II
Quantity
3 kits (number of vials per kit vary by prescription)
Official record key
drug-enforcement:D-0394-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@100. Known vial lot code: 05042016@94.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility