Sermorelin Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable products are classified as Severe (Score 4) due to the significant risk of infection or injury, even without explicit reports of hospitalization in the provided text.
Plain-English summary
The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE. The recall covers 77 ml vials distributed nationwide between November 2014 and May 2015. Specific lots affected include 04092015@84, 04062015@55, 04222015@104, and 04292015@47.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and potentially impact the overall quality of the product.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Sermorelin 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@84
- 6/8/2015
- 04062015@55
- 6/5/2015
- 04222015@104
- 6/21/2015
- 04292015@47
- 6/28/2015
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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