The Recall Desk
HighFDA (Drugs)·D-1210-2022·Announced 2022-07-20

Compounded injectable product recalled for lack of sterility assurance

Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.

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 of an injectable product with lack of sterility assurance, representing a risk-of-harm scenario where injury has not yet been reported. The source text does not report any illnesses or hospitalizations.

Plain-English summary

Tailor Made Compounding (TMC Acquisition LLC) is recalling 25 vials of a compounded injectable product containing inositol, choline, B12, and carnitine. The recalled batches are: Batch 01212203A2 (expires 4/21/2022) and Batch 02232213A1 (expires 5/24/2022).

The product is being recalled due to lack of assurance of sterility. This means the manufacturer cannot confirm the product is free from contamination before reaching patients.

The affected product was distributed nationwide in the USA and Puerto Rico.

Those in possession of the recalled batches should not use the product and should contact Tailor Made Compounding for guidance.

The recalled product

Product
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-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 (4)

  • Batch#: 01212203A2
  • Exp 4/21/2022
  • 02232213A1
  • Exp 5/24/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category