Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns
Pharm D Solutions is recalling Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.
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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in injectable products.
Plain-English summary
Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 9 mg/9 mg Powder (NDC 69699-1715-10). The recall was initiated because the company lacks assurance that the product is sterile. The affected product consists of 250 vials and was distributed nationwide.
The specific lots subject to the recall are 03202018:46 (discard by 9/16/2018) and 05012018:56 (discard by 10/28/2018). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact Pharm D Solutions, LLC or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Powder
- Hazard
- Affected units
- 250
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: 03202018:46 Discard by: 9/16/2018
- 05012018:56 Discard by: 10/28/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 79 recalled by Pharm D Solutions, LLC 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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