Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns
Pharm D Solutions is recalling 124 vials of Sermorelin/GHRP-2 powder nationwide 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable powders) are mapped to a score of 4 (Severe) to ensure appropriate caution, as Class I is reserved for Class I recalls or reported deaths.
Plain-English summary
Pharm D Solutions, LLC is recalling 124 vials of Sermorelin/GHRP-2 18 mg/6 mg powder (NDC 69699-1748-10). The recall was initiated because the company lacks assurance of the product's sterility.
The affected product is identified by Lot 04232018:89 and has a discard-by date of 10/15/2018. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact Pharm D Solutions for further instructions or a refund.
The recalled product
- Product
- Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Powder
- Affected units
- 124
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 (1)
- Lot: 04232018:89 Discard by: 10/15/2018
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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