Semaglutide-Glycine-Cyanocobalamin Injectable Vials Recalled Due to Lack of Sterility Assurance
Payless Compounders, LLC is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials because there is no assurance that the product is sterile.
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 involves a lack of sterility assurance for an injectable medication, which poses a significant risk of harm.
Plain-English summary
Payless Compounders, LLC is recalling Semaglutide-Glycine-Cyanocobalamin Injectable (2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials) due to a lack of assurance of sterility.
The affected product includes Lot Number [email protected]. The distribution is limited to Oregon.
Consumers and healthcare providers should check their stock for the affected lot number and contact the manufacturer or their healthcare provider for further guidance.
The recalled product
- Product
- Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
- Manufacturer
- PAYLESS COMPOUNDERS, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 91
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 (1)
- Lot Number [email protected]
Distribution
Distributed in 1 state:
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