Gonadorelin Drug Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
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 for a sterility assurance failure on an injectable pharmaceutical product. No illnesses or injuries have been reported. The hazard represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for High (3) severity.
Plain-English summary
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide, including Puerto Rico, because the manufacturer cannot provide sufficient assurance that the recalled vials meet required sterility standards.
The affected vials were distributed under the following batch numbers: 01062225B (Exp 4/6/2022), 01142207A1 (Exp 4/14/2022), 02012228A1 (Exp 5/2/2022), 02032203A1 (Exp 5/4/2022), 03012211A1 (Exp 5/30/2022), and 03082240A1 (Exp 6/6/2022). If you have received these vials, do not use them. Contact Tailor Made Compounding or your healthcare provider for further instructions.
The recalled product
- Product
- Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- 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 (12)
- Batch #: 01062225B
- Exp 4/6/2022
- 01142207A1
- Exp 4/14/2022
- 02012228A1
- Exp 5/2/2022
- 02032203A1
- Exp 5/4/2022
- 03012211A1
- Exp 5/30/2022
- 03082240A1
- Exp 6/6/2022.
Distribution
Distributed nationwide across the United States.
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