Sermorelin and GHRP-2 Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Sermorelin and GHRP-2 injections due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential sterility issues (implying risk of infection/hospitalization) are categorized as Severe (Score 4).
Plain-English summary
The Compounding Pharmacy of America is recalling Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a sterile injection intended for refrigeration. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 04012015@76 (expiration 5/31/2015) and 04062015@11 (expiration 6/5/2015). The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
- Hazard
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 (5)
- All lots distributed between November 2014 and May 2015
- 04012015@76
- 5/31/2015
- 04062015@11
- 6/5/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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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