Sermorelin/GHRP6 Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Sermorelin/GHRP6 Injection due to FDA inspection findings of GMP violations that impact sterility assurance.
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 and involves a sterile injection product where sterility assurance is compromised, posing a risk of serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial. The recall was initiated 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 nationwide between November 2014 and May 2015. The total volume of the recalled product is 185 ml.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Sermorelin/GHRP6 1000/1000 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 — 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 (20)
- All lots distributed between November 2014 and May 2015
- 05072015@31
- 7/6/2015
- 03232015@11
- 5/22/2015
- 03302015@44
- 5/29/2015
- 03272015@16
- 5/26/2015
- 04222015@81
- 6/1/2015
- 04032015@15
- 6/2/2015
- 04142015@9
- 6/13/2015
- 04232015@11
- 6/22/2015
- 04272015@42
- 6/26/2015
- 04292015@86
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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