Agency classClass IIOur severity:High FDA (Drugs)·D-1223-2022·Announced 2022-07-20

PT-141 10mg/mL Injectable Vials Recalled for Sterility Assurance Concerns

Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.

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 a potential for microbial contamination in an injectable drug product. The source reports no illnesses or injuries and the hazard is theoretical, placing this at the High severity level per the rubric.

Plain-English summary

Tailor Made Compounding is recalling PT-141 10mg/mL vials due to lack of assurance of sterility. The recall affects 392 vials in two sizes: 1mL and 2mL vials that require refrigeration.

The reason for the recall is that the manufacturer cannot assure that the vials meet sterility requirements. This is a Class II recall issued by the U.S. Food and Drug Administration.

The affected vials were distributed nationwide in the United States and Puerto Rico. The specific batch numbers are: for 1mL vials - 01042226A2 (expires 4/4/2022), 01242228A2 (expires 4/24/2022), 02212208A1 (expires 5/22/2022); for 2mL vials - 01192230A2 (expires 4/19/2022), 02212217A1 (expires 5/22/2022).

Consumers or healthcare providers who have these products should not use them and should contact Tailor Made Compounding.

The recalled product

Product: PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug
Hazard: sterility-assurance
microbial-contamination
Affected units: 392

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 (10)

Batch#: a) 01042226A2
Exp 4/4/2022
01242228A2
Exp 4/24/2022
02212208A1
Exp 5/22/2022
b) 01192230A2
Exp 4/19/2022
02212217A1
Exp 5/22/2022.

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

Same hazard · sterility assurance