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.
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 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
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.
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