Apollo Care Recalls Semaglutide Vials Due to Particulate Matter
Apollo Care is recalling 250 vials of Semaglutide 7.5mg due to the presence of nylon and silk-type 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential injury risks such as particulate matter in injectable drugs.
Plain-English summary
Apollo Care, LLC is recalling 250 vials of Semaglutide 7.5mg (5mg/mL) sterile multi-dose vials. The product is identified by NDC 71170-721-01, Lot AC-017273, and an expiration date of 12/12/2026.
The recall was initiated because of the presence of particulate matter in the product. The particulate matter has been identified as nylon/polyamide and silk/proteinaceous-type material. The agency has classified this recall as Class II.
The affected product was distributed nationwide within the U.S. Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
- Manufacturer
- Apollo Care, LLC
- Category
- Drug — Injectable
- 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-017273
- Exp. 12/12/2026.
Distribution
Distributed nationwide across the United States.
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