Pharm D Solutions Recalls Sermorelin/Ipamorelin Powder Due to Sterility Concerns
Pharm D Solutions is recalling 179 vials of Sermorelin/Ipamorelin 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is mapped to a score of 4 (Severe).
Plain-English summary
Pharm D Solutions, LLC is recalling 179 vials of Sermorelin/Ipamorelin 18 mg/15 mg Powder (NDC 69699-1759-18). The recall was initiated because the company lacks assurance of the product's sterility. The affected lot is 07272018:31, with a discard-by date of 1/23/2019.
The product was distributed nationwide. 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, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions for further instructions or a refund.
The recalled product
- Product
- Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Powder
- Hazard
- Affected units
- 179
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: 07272018:31 Discard by: 1/23/2019
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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