Agency classClass IIOur severity:High FDA (Drugs)·D-1195-2022·Announced 2022-07-20

Ascorbic Acid Injectable Vials Recalled Due to Sterility Assurance Failure

Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II recall involves lack of sterility assurance in an injectable pharmaceutical product, representing a risk-of-harm situation. No illnesses or injuries have been reported in the source text, placing this at the High severity level per the rubric criteria.

Plain-English summary

Tailor Made Compounding is recalling ascorbic acid 500mg/mL injectable vials because the company cannot assure that the product meets sterility standards. Affected vials include both 25 mL and 50 mL formats across multiple batches, totaling 657 units distributed nationwide in the USA and Puerto Rico.

A non-sterile injectable product poses a risk of serious infection to patients who receive it. The affected batch numbers and expiration dates are listed in FDA recall notice D-1195-2022.

Patients and healthcare providers who have or dispense these vials should stop use immediately. Contact Tailor Made Compounding or your pharmacy to return the product or for information about affected batches.

The recalled product

Product: Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Injectable / Compounded
Hazard: sterility-failure
infection-risk
Affected units: 657

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 #: a) 02282223A1
Exp 8/27/2022
10112101A2
Exp 4/9/2022
11032108A1
Exp 4/30/2022
11222101A2
Exp 5/21/2022
b) 01042234B
Exp 7/3/2022
01242211A2
Exp 7/23/2022
02282222A1
10182101A1
Exp 4/16/2022
11162112A1
Exp 5/15/2022
12062105A2
Exp 6/4/2022
12142143A2

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

See all →

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FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
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Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20

Same hazard · sterility failure