The Recall Desk
HighFDA (Drugs)·D-1224-2022·Announced 2022-07-20

Semaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance

Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.

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 risk-of-harm product—an injectable medication that requires sterile manufacturing conditions. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not been reported are classified as High (score 3).

Plain-English summary

Tailor Made Compounding is recalling 5,842 vials of semaglutide/cyanocobalamin 2mg/0.4mg per milliliter in 1-milliliter vials. Multiple batch numbers are affected, with expiration dates ranging from March through June 2022.

The recall was issued due to lack of assurance of sterility. The manufacturer could not provide adequate verification that the product was manufactured under the required sterile conditions for injectable medications.

The affected product was distributed nationwide throughout the United States and Puerto Rico. Healthcare providers and patients who have received this product should be aware of the recall and verify which batch numbers they possess.

Patients and healthcare providers should contact their healthcare provider regarding any product they may have received. Do not use any remaining product from affected batches.

The recalled product

Product
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable / Compounded
Hazard
  • lack-of-sterility
  • 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 (20)

  • Batch#: 12032123A2
  • Exp 3/3/2022
  • 12102101A2
  • Exp 3/10/2022
  • 12202105A2
  • Exp 3/20/2022
  • 12292106A2
  • Exp 3/29/2022
  • 01062218B
  • Exp 4/6/2022
  • 01192228A2
  • Exp 4/19/2022
  • 01312214A2
  • Exp 5/1/2022
  • 02012211A1
  • Exp 5/2/2022
  • 02182201A1
  • 02182203A1
  • Exp 5/19/2022
  • 02242205A1

Distribution

Distributed nationwide across the United States.

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