Semaglutide and Cyanocobalamin Injectable Recalled for Processing Control Deficiencies
Aequita Pharmacy is recalling 194 vials of Semaglutide + Cyanocobalamin injectable solution due to lack of manufacturing process controls. The affected product was 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: This is a Class II FDA drug recall for lack of manufacturing process controls in a sterile injectable product. The processing control deficiency poses a potential risk of contamination with no illnesses or injuries reported, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Aequita Pharmacy LLC is recalling 194 vials of Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injectable solution. The product is supplied in sterile, 2 mL multi-dose vials requiring refrigeration.
The FDA classified this recall as Class II due to lack of processing controls during manufacturing. Processing control deficiencies can compromise the sterility and quality of injectable pharmaceutical products.
The recalled product was distributed in Massachusetts. All lot numbers within distribution remain within their expiration dates.
Patients currently taking this product should contact their healthcare provider. Healthcare providers and patients should reach out to Aequita Pharmacy for recall instructions and alternative treatment options.
The recalled product
- Product
- Semaglutide + Cyanocobalamin 0.88 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
- Hazard
- contamination
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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