The Recall Desk
CriticalFDA (Drugs)·D-1052-2014·Announced 2014-02-05

NuVision Pharmacy Recalls Sermorelin/GHRP-6 Vials Due to Sterility Concerns

NuVision Pharmacy is recalling 122 vials of Sermorelin/GHRP-6 due to lack of sterility assurance identified during an FDA inspection.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

NuVision Pharmacy, Inc. is recalling 122 vials of Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740. The product was compounded by NuVision Pharmacy in Dallas, TX, and distributed nationwide.

The recall was initiated due to a lack of sterility assurance and concerns associated with quality control processes identified during an FDA inspection. The specific lot number is N10172012@11, with an expiration date of 10/17/2013.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
Affected units
122

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by NuVision Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · NuVision Pharmacy, Inc.

See all →