Sermorelin/Glycine Injectable Recalled for Lack of Sterility Assurance
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
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 sterility failure in an injectable product. This is a risk-of-harm product where no illnesses or injuries have been reported, meeting the High (3) severity threshold per the rubric.
Plain-English summary
Tailor Made Compounding is recalling Sermorelin/Glycine 2000mcg/5mg/mL injectable solution in 7.5mL vials. The affected product was distributed nationwide, including Puerto Rico.
The recall was initiated due to lack of assurance of sterility. The manufacturer could not adequately demonstrate that the product meets sterility standards required for injectable medications.
Approximately 2,870 vials are affected across multiple batches with expiration dates ranging from March 2022 through June 2022. The product was distributed to healthcare providers and compounding pharmacies nationwide.
Patients who have received this medication should consult their healthcare provider. Healthcare providers should stop dispensing the product and contact patients who may have received it to determine if alternative treatment is appropriate.
The recalled product
- Product
- Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
- contamination-risk
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 (20)
- Batch #: 10122102A2
- Exp 3/22/2022
- 10252101A2
- Exp 3/24/2022
- 11092106A2
- Exp 4/8/2022
- 11232102A1
- Exp 5/7/2022
- 11162106A1
- Exp 5/15/2022
- 12032114A1
- 02212224A1
- Exp 5/22/2022
- 12142111A1
- 12202109A2
- Exp 5/24/2022
- 03032244A1
- Exp 6/1/2022
- 03082209A1
- Exp 6/6/2022
Distribution
Distributed nationwide across the United States.
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