The Recall Desk
HighFDA (Drugs)·D-1213-2022·Announced 2022-07-20

Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns

Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.

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 medication where sterility assurance cannot be verified. Injectable products pose higher risk if contaminated with pathogens. No illnesses or injuries have been reported, making this a theoretical but significant risk-of-harm scenario.

Plain-English summary

Tailor Made Compounding has recalled 924 vials of Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL injectable compound due to lack of assurance of sterility. The recall affects multiple batch numbers across 4mL, 10mL, and 30mL vials distributed nationwide in the USA and Puerto Rico.

Affected batch numbers include: 4mL vials (01172233A1 exp 4/17/2022, 01282213A1 exp 4/28/2022, 02192221A1 exp 5/20/2022); 10mL vials (12032118A2 exp 3/3/2022, 12282120A2 exp 3/28/2022, 01172233A1 exp 4/17/2022, 01282213A1 exp 4/28/2022, 02212242A1 exp 5/22/2022, 03042202A1 exp 6/2/2022); and 30mL vials (02192219A1 exp 5/20/2022, 03062201A1 exp 6/4/2022).

Patients currently using this product should contact their healthcare provider immediately. All affected vials should be stopped immediately and returned to the pharmacy or manufacturer. The manufacturer initiated this recall because it cannot assure the product meets required sterility standards.

The recalled product

Product
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable Compounded Medication
Hazard
  • sterility-assurance
  • 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 (17)

  • Batch#: a) 01172233A1
  • Exp 4/17/2022
  • 01282213A1
  • Exp 4/28/2022
  • 02192221A1
  • Exp 5/20/2022
  • b)12032118A2
  • Exp 3/3/2022
  • 12282120A2
  • Exp 3/28/2022 01172233A1
  • 02212242A1
  • Exp 5/22/2022
  • 03042202A1
  • Exp 6/2/2022
  • c) 02192219A1
  • 03062201A1
  • Exp 6/4/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category