Sermorelin/GHRP2 Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Sermorelin/GHRP2 Injection 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be lower.
Plain-English summary
The Compounding Pharmacy of America is recalling Sermorelin/GHRP2 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 quality and sterility of the product.
The affected product is a sterile injection with a total volume of 43 ml. It was distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates associated with the recall include 04092015@9, 04152015@59, 04042015@26, and 04132015@36.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. 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/GHRP2 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 (9)
- All lots distributed between November 2014 and May 2015
- 04092015@9
- 6/8/2015
- 04152015@59
- 6/14/2015
- 04042015@26
- 6/6/2015
- 04132015@36
- 6/12/2015
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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