Tirzepatide + Niacinamide Injectable Recalled for Manufacturing Control Deficiency
Aequita Pharmacy is recalling 143 vials of Tirzepatide + Niacinamide injection solution due to inadequate processing controls during manufacturing. The medication 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 an FDA Class II recall involving deficient manufacturing controls on a sterile injectable medication. No illnesses or injuries have been reported. Per the severity rubric, Class II recalls without documented adverse events qualify as High severity due to the inherent risk of manufacturing defects in sterile products.
Plain-English summary
Aequita Pharmacy LLC, located in Kirkland, Washington, is recalling 143 vials of Tirzepatide + Niacinamide 13.2 mg + 1.0 mg/0.5 mL injection solution in 2 mL multi-dose sterile vials due to inadequate processing controls during manufacturing. All recalled vials are within their expiration date.
The medication was distributed in Massachusetts. Deficiencies in manufacturing controls on sterile injectable products create a potential risk to patients, though no illnesses or injuries have been reported.
Patients currently using this medication should consult their healthcare provider before making any changes to their treatment. Unused vials should be returned to the pharmacy where they were dispensed or contact Aequita Pharmacy for return instructions.
The recalled product
- Product
- Tirzepatide + Niacinamide 13.2 mg + 1.0mg/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
- manufacturing-defect
- quality-control-deficiency
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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