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
- 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.
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