The Recall Desk
HighFDA (Drugs)·D-1202-2022·Announced 2022-07-20

Folic Acid Injectable Vials Recalled Due to Sterility Concerns

TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in 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 (injectable medication) with no reported illnesses or injuries. Lack of sterility assurance in an injectable poses a potential infection risk, but the absence of reported adverse events places it at High per the rubric.

Plain-English summary

Tailor Made Compounding (TMC Acquisition LLC) is recalling Folic Acid 5mg/mL injectable vials in 30mL refrigerated containers. The recall is due to lack of assurance of sterility in the manufacturing process.

The recall affects 45 units that were distributed nationwide in the USA and Puerto Rico. Affected batches include: 10132102A2 (Exp 3/22/2022), 01062221B (Exp 4/30/2022), 11302103A1 (Exp 4/30/2022), and 03032227A1 (Exp 8/29/2022).

Healthcare providers and patients should not use affected vials. Consult with a healthcare provider or pharmacist about proper return or disposal of recalled product.

The recalled product

Product
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable / Folic Acid
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 (7)

  • Batch#: 10132102A2
  • Exp 3/22/2022
  • 01062221B
  • Exp 4/30/2022
  • 11302103A1
  • 03032227A1
  • Exp 8/29/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category