Apollo Care Recalls Semaglutide Vials Due to Particulate Matter
Apollo Care, LLC is recalling 250 vials of Semaglutide 2.5mg due to the presence of nylon and silk particulate matter.
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, and the presence of particulate matter in a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Apollo Care, LLC is recalling 250 vials of Semaglutide 2.5mg (1mg/mL) sterile multi-dose vials. The product is identified by NDC 71170-711-02, Lot AC-017271, and an expiration date of 12/12/2026. The recall was initiated because the vials contain particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.
The affected product was distributed nationwide within the U.S. This recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers and healthcare providers should stop using the affected vials and contact Apollo Care, LLC or their healthcare provider for further instructions.
The recalled product
- Product
- SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 250
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: AC-017271
- Exp. 12/12/2026.
Distribution
Distributed nationwide across the United States.
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