Agency classClass IIOur severity:High FDA (Drugs)·D-1212-2022·Announced 2022-07-20

Melanotan I Injectable Vials Recalled Due to Lack of Sterility Assurance

Tailor Made Compounding has recalled 182 vials of Melanotan I injectable due to lack of assurance of sterility. 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 is an FDA Class II recall of an injectable drug product without reported illnesses or injuries. While lack of sterility assurance in injectable medications presents a serious potential risk of contamination, the absence of reported adverse events limits the severity to High per the rubric criteria.

Plain-English summary

Tailor Made Compounding has recalled 182 vials of Melanotan I 200mcg/mL (2mg/ml) injectable solution. The recall includes two vial sizes: 1.5mL and 5mL vials that require refrigeration.

The manufacturer initiated the recall due to lack of assurance of sterility. This means the product did not meet the required sterility standards for injectable medications.

The affected vials were distributed nationwide in the United States and to Puerto Rico. Multiple batch numbers are involved with expiration dates ranging from March 16, 2022 to June 1, 2022. Consumers and healthcare providers who have received these vials should not use them and should contact the manufacturer or their healthcare provider for guidance.

The recalled product

Product: Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Injectable / Compounded
Hazard: sterility-assurance
Affected units: 182

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 (11)

Batch #: a) 01072212A1
Exp 4/7/2022
03032220A1
Exp 6/1/2022
b) 12162120A2
Exp 3/16/2022
01142205A1
Exp 4/14/2022
02012226A1
Exp 5/2/2022
Exp 6/1/2022.

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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Same hazard · sterility assurance