Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and 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 for a compounded injectable product with lack of assurance of sterility, which presents a risk of harm to patients through potential contamination. No reported illnesses or hospitalizations are mentioned in the source text, so per the rubric, the score does not exceed 3.
Plain-English summary
Tailor Made Compounding is recalling 349 vials of Estradiol Cypionate 10mg/mL (a hormone medication) distributed nationwide in the USA and Puerto Rico. The recall affects both 1mL and 2mL vials with batch numbers 01052210A1, 10202101A1, 10202102A1, 12022126A1, and 01052210A1, with expiration dates ranging from April to July 2022.
The recall was initiated due to lack of assurance of sterility. Estradiol Cypionate is a compounded injectable medication, and sterility assurance is critical for injectable products to prevent contamination and infection.
Patients and healthcare providers who may have received or administered affected vials matching the recalled batch numbers and expiration dates should contact Tailor Made Compounding for further guidance.
The recalled product
- Product
- Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- 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 (10)
- Batch #: a) 01052210A1
- Exp 4/5/2022
- 10202101A1
- Exp 4/18/2022
- 01052210A1 7/4/2022
- b)10202102A1
- 12022126A1
- Exp 5/31/2022
- 01052210A1
- Exp 7/4/2022.
Distribution
Distributed nationwide across the United States.
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