Critical RiskFDA Drug

NuVision Pharmacy, Inc.: 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.

Agency Publication Date: October 4, 2013

Affected Products

Product: HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15

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

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

Lot Numbers:

N10172012

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64922

Status: Resolved

Manufacturer: NuVision Pharmacy, Inc.

Manufactured In: United States

Units Affected: 2 products (285 vials; 122 vials)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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