The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1327-2019·Announced 2019-06-19

FDA Recalls Ipamorelin Acetate Injectable Vials Due to Sterility Concerns

Pharm D Solutions is recalling 11 vials of Ipamorelin Acetate 9 mg/9mL Injectable due to a lack of sterility assurance.

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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard of lack of sterility assurance in an injectable product poses a significant risk of infection, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Ipamorelin Acetate 9 mg/9mL Injectable vials. The recall is being conducted by Pharm D Solutions, LLC, located in Houston, Texas. The specific reason for the recall is a lack of sterility assurance.

The affected product consists of 11 vials of Ipamorelin Acetate, which is a prescription-only medication. The recall covers two specific lots: Lot 05022019:50 with an expiration date of 10/29/2019, and Lot 05082019:91 with an expiration date of 06/08/2019. The product was distributed nationwide within the United States.

Consumers and healthcare providers who have this product should stop using it and contact Pharm D Solutions at 1-844-263-6846 for further instructions on how to return or dispose of the medication.

The recalled product

Product
Ipamorelin Acetate 9 mg/9mL Injectable 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
Hazard
Affected units
11

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 #: 05022019:50 Exp. 10/29/2019
  • 05082019:91 Exp. 06/08/2019

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 →

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