The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0179-2019·Announced 2018-11-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.

See all 79 products in this recall →

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