Compounded Sermorelin/Glycine Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine injectable distributed nationwide because the manufacturer cannot assure the product meets sterility standards. Patients should stop using the recalled product and contact their healthcare provider.
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 of an injectable pharmaceutical with lack of sterility assurance. This constitutes a risk-of-harm product where injury has not yet been reported. No illnesses, hospitalizations, or deaths have been reported in the source text.
Plain-English summary
Tailor Made Compounding is recalling 1,562 vials of Sermorelin/Glycine 2000mcg/5mg/mL in 4mL vials distributed nationwide in the United States and Puerto Rico. The recall affects multiple batch numbers with expiration dates ranging from April 2022 through June 2022. The recall was initiated because the manufacturer cannot assure that the product meets required sterility standards.
The recalled product is a compounded injectable pharmaceutical requiring refrigeration. Lack of sterility assurance in injectable products poses a potential risk of contamination and infection if vials have been compromised during manufacturing or storage.
Patients currently using the recalled product should stop using it and contact their healthcare provider immediately for guidance. Healthcare providers and pharmacists should not dispense the recalled vials. Users should reference the affected batch numbers and expiration dates provided by the FDA (recall number D-1227-2022). Healthcare facilities should check their inventory and quarantine any vials matching the affected batch numbers.
The recalled product
- Product
- Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility-assurance
- 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 (16)
- Batch#: 11102107A2
- Exp 4/9/202211232104A1
- Exp 5/7/2022
- 02212229A1
- 11292103A2
- Exp 5/22/2022
- 12132105A2
- Exp 5/24/2022
- 02282207A1
- Exp 5/29/2022
- 03082209A1
- Exp 6/6/2022
- 03112231B
- Exp 6/9/2022
- 01042212A1
- Exp 6/27/2022.
Distribution
Distributed nationwide across the United States.
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