The Recall Desk
HighFDA (Drugs)·D-1192-2022·Announced 2022-07-20

Alpha Lipoic Acid injectable vials recalled for sterility assurance failure

TMC Acquisition LLC is recalling Alpha Lipoic Acid 25mg/mL vials due to lack of assurance of sterility in manufacturing. The product was 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 a Class II FDA drug recall for a sterile injectable with a manufacturing sterility assurance defect. No illnesses or injuries have been reported in the source text. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, placing it at Score 3 (High).

Plain-English summary

Alpha Lipoic Acid 25mg/mL injectable vials (30mL per vial) manufactured by TMC Acquisition LLC dba Tailor Made Compounding are being recalled nationwide in the USA and Puerto Rico.

The product is being recalled due to lack of assurance of sterility in the manufacturing process. Affected batches include #12082102A2 (expiration 3/8/2022) and #02212201A1 (expiration 5/22/2022). This is a Class II recall issued by the FDA.

Consumers and healthcare providers in possession of the recalled product should cease use immediately and contact their healthcare provider or the manufacturer for guidance on proper handling and replacement.

The recalled product

Product
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable / Compounded
Hazard
  • sterility-failure

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 #: 12082102A2
  • Exp 3/8/2022
  • 02212201A1
  • Exp 5/22/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category