The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1330-2019·Announced 2019-06-19

Pharm D Solutions Recalls Sermorelin/Ipamorelin Vials Due to Sterility Concerns

Pharm D Solutions is recalling Sermorelin/Ipamorelin 18 mg/15 mg vials because they lack sterility assurance. The recall covers 24 vials distributed nationwide.

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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports or high-risk conditions.

Plain-English summary

Pharm D Solutions, LLC is recalling Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, which are prescription-only medications. The recall is being conducted because the product lacks sterility assurance. The affected product consists of 24 vials and was distributed nationwide within the United States.

The specific lots involved in this recall are 04162019:48 (Expiration 10/13/2019), 04302019:70 (Expiration 10/27/2019), and 05022019:34 (Expiration 10/29/2019). The manufacturer is Pharm D Solutions, LLC, located in Houston, Texas.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions at 1-844-263-6846 for further instructions or a refund.

The recalled product

Product
Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
24

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 (3)

  • Lot #: 04162019:48 Exp. 10/13/2019
  • 04302019:70 Exp. 10/27/2019
  • 05022019:34 Exp. 10/29/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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 18 products in this recall →

Related recalls

Same manufacturer · Pharm D Solutions, LLC

See all →

Same hazard · lack of sterility

See all →

Similar recalls