Semaglutide Injection Recalled for Manufacturing Process Control Deficiency
Aequita Pharmacy is recalling 190 vials of Semaglutide + Cyanocobalamin injection due to inadequate manufacturing process controls. Affected vials were distributed in Massachusetts.
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: FDA Class II classification for an injectable medication with manufacturing process control deficiency. The recall of a sterile injectable product due to compromised quality control processes presents a theoretical risk of harm despite the absence of reported adverse events.
Plain-English summary
Aequita Pharmacy LLC in Kirkland, Washington is recalling 190 vials of Semaglutide + Cyanocobalamin injectable solution (1.5 mg + 0.25 mg per 0.5 mL). The recall affects product distributed in Massachusetts.
The recall was initiated due to lack of adequate processing controls during manufacturing. Proper process controls are critical to ensure the safety and sterility of injectable medications.
Patients currently using this medication should contact their healthcare provider to determine if they should continue use or obtain an alternative supply. Affected vials include all lots within expiry.
For additional information, contact Aequita Pharmacy LLC in Kirkland, Washington.
The recalled product
- Product
- Semaglutide +Cyanocobalamin 1.5 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
- Hazard
- manufacturing-defect
- inadequate-process-controls
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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