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Recall Observatory FDA recall evidence

Drug product

Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244

D-1052-2014

April 15, 2013

Class I

Product summary

Firm
NuVision Pharmacy, Inc.
Event
Event 64922
Status
Terminated
Classification
Class I
Quantity
122 vials
Official record key
drug-enforcement:D-1052-2014

Official wording

Reason: Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

Code information: Lot #:N10172012@11, Exp 10/17/2013

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility