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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Manufacturer
- NuVision Pharmacy, Inc.
- Category
- Drug — Compounded Injectable
- 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 →Related recalls
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