Sermorelin Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,208 vials of Sermorelin due to inability to assure sterility. The product was distributed nationwide in the USA and Puerto Rico across multiple batch lots.
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: FDA Class II recall for a compounded pharmaceutical with sterility concerns. Per the rubric, this qualifies as a risk-of-harm product where potential microbial contamination from lack of sterility assurance is not accompanied by reported injuries or illnesses.
Plain-English summary
Tailor Made Compounding is recalling 1,208 vials of Sermorelin 2000mcg/mL (7.5mL vials) due to lack of assurance of sterility. The affected vials were distributed nationwide in the USA and Puerto Rico. Specific affected batches include: 10122103A2 (expires 3/22/2022), 11092108A2 (expires 4/30/2022), 11192115A2 (expires 5/7/2022), 12022107A2 (expires 5/22/2022), 12132107A2 (expires 5/24/2022), 01182201A2 (expires 6/30/2022), 02142212A1 (expires 8/13/2022), and 03022217A1 (expires 8/29/2022).
The FDA classified this as a Class II recall due to the manufacturer's inability to assure that the vials met required sterility standards.
Consumers and healthcare providers should stop using affected batches immediately. Anyone who has received affected product should consult their healthcare provider or contact Tailor Made Compounding for guidance on replacements or alternative sources.
The recalled product
- Product
- Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug
- Hazard
- lack-of-sterility
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 (16)
- Batch#: 10122103A2
- Exp 3/22/2022
- 11092108A2
- Exp 4/30/2022
- 11192115A2
- Exp 5/7/2022
- 12022107A2
- Exp 5/22/2022
- 12132107A2
- Exp 5/24/2022
- 01182201A2
- Exp 6/30/2022
- 02142212A1
- Exp 8/13/2022
- 03022217A1
- Exp 8/29/2022.
Distribution
Distributed nationwide across the United States.
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