The Recall Desk
HighFDA (Drugs)·D-1225-2022·Announced 2022-07-20

Compounded Semaglutide/Cyanocobalamin Vials Recalled Over Sterility Concerns

Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been 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: FDA Class II recall of an injectable compounded medication. However, no illnesses or adverse events have been reported, and the hazard is a theoretical risk (lack of sterility assurance) rather than confirmed contamination or known adverse outcomes.

Plain-English summary

Tailor Made Compounding is recalling 9,993 vials of a compounded injection containing semaglutide/cyanocobalamin 5mg/0.2mg/ml (2ml vials). The product was distributed nationwide in the USA and Puerto Rico to healthcare providers and patients.

The recall was initiated due to lack of assurance of sterility. This quality issue affects the product's ability to meet sterility standards required for injectable medications.

Affected batches have expiration dates from March 9, 2022 through June 7, 2022, with multiple batch codes identified. Patients who have received this product should contact their healthcare provider or pharmacist for guidance.

No adverse events or illnesses have been reported. The FDA classified this as a Class II recall. Healthcare providers and patients with questions should contact Tailor Made Compounding or their local FDA office.

The recalled product

Product
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Compounded Injectable
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#: 12092115A2
  • Exp 3/9/2022
  • 12162116A2
  • Exp 3/16/2022
  • 12212106A2
  • Exp 3/21/2022
  • 01062219B
  • Exp 4/6/2022
  • 01072205A1
  • 01072208A1
  • Exp 4/7/2022
  • 01102203A1
  • Exp 4/10/2022
  • 01132207A1
  • Exp 4/13/2022
  • 01192216A1
  • Exp 4/19/2022
  • 01202204A2
  • Exp 4/20/2022
  • 01272223A2

Distribution

Distributed nationwide across the United States.

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