Semaglutide and Cyanocobalamin Injectable Solution Recalled for Manufacturing Control Deficiency
Aequita Pharmacy recalled 221 vials of Semaglutide and Cyanocobalamin injectable solution (distributed in Massachusetts) due to lack of manufacturing process controls. No illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a high-risk injectable drug product with manufacturing control deficiencies. Although no illnesses or injuries have been reported, the lack of processing controls on an injectable represents a risk-of-harm product situation, matching the Score 3 criterion.
Plain-English summary
Aequita Pharmacy LLC, located in Kirkland, Washington, has recalled 221 vials of Semaglutide and Cyanocobalamin 0.44 mg/0.25 mg per 0.5 mL injectable solution. The product consists of 2 mL multi-dose vials intended for subcutaneous injection and requiring refrigeration.
The recall was issued due to a lack of processing controls during manufacturing. This manufacturing control deficiency poses a potential risk to the quality and safety of the product.
The affected vials were distributed in Massachusetts. All affected product lots remain within their expiration dates at the time of this recall notice.
No illnesses or injuries have been reported related to this product. Patients currently using this medication should contact their healthcare provider to discuss the recall and determine appropriate next steps.
The recalled product
- Product
- Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
- Manufacturer
- AEQUITA PHARMACY
- Category
- Drug — Injectable Solution
- Hazard
- quality-control-failure
- contamination-risk
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)
- All Lots within expiry.
Distribution
Distributed in 1 state:
- MA
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