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.
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, 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.
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