Agency classClass IIOur severity:High FDA (Drugs)·D-1196-2022·Announced 2022-07-20

BCAA Injection Vials Recalled for Lack of Sterility Assurance

Tailor Made Compounding is recalling 180 vials of BCAA (branched-chain amino acid) injections nationwide due to inability to assure the product maintained sterility. Affected batches expire between April and June 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 recall received a High severity rating because it involves a risk-of-harm product (injectable medication) with theoretical risk based on lack of sterility assurance but no reported illnesses or injuries. Per FDA rubric, such risk-of-harm products without reported injury score at maximum 3.

Plain-English summary

Tailor Made Compounding is recalling BCAA (branched-chain amino acid) injections due to lack of assurance of sterility. The recalled product contains leucine, isoleucine, and valine in a concentration of 10mg/10mg/5mg per mL, supplied in 30mL vials. Approximately 180 vials were distributed nationwide in the United States and Puerto Rico.

The affected batches are: Batch #11022106A1 (expires 4/30/2022), #11192106A2 (expires 5/18/2022), #12022105A1 (expires 5/31/2022), #12132108A1 (expires 6/11/2022), and #12292117A1 (expires 6/27/2022).

The FDA classified this recall as Class II because the manufacturer was unable to provide assurance that the product maintained sterility. No illnesses or injuries from use of these vials have been reported.

The recalled product

Product: BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Injectables
Hazard: sterility-failure
Affected units: 180

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 #: 11022106A1
Exp 4/30/2022
11192106A2
Exp 5/18/2022
12022105A1
Exp 5/31/2022
12132108A1
Exp 6/11/2022
12292117A1
Exp 6/27/2022.

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

Same hazard · sterility failure