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.
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 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.
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