IVME HCG Vitamin B Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling IVME HCG Vitamin B injectable in the United States due to lack of assurance of sterility. The product was distributed as a prescription-only injectable.
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 involving a sterile injectable product with compromised sterility assurance. Although no illnesses or injuries are explicitly reported in the source, sterile injectable products with loss of sterility assurance present a high risk of serious harm, including infection and sepsis. This meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling IVME HCG VITAMIN B INJ (which contains no HCG) due to lack of assurance of sterility. The product is an injectable medication available by prescription only.
The affected product consists of 122 vials distributed across the United States, including Washington, D.C. and Puerto Rico. The recalled lots are: Lot 09092021:04 with Beyond Use Date (BUD) of 12/09/2021, and Lot 07262021:55 with BUD of 10/24/2021.
The manufacturer is located at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247. Patients who have received this product should consult their healthcare provider. The product should not be used.
The recalled product
- Product
- IVME HCG VITAMIN B INJ (CONTAINS NO HCG) INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance
- infection-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 (2)
- Lot: 09092021:04 BUD: 12/09/2021
- 07262021:55 BUD: 10/24/2021
Distribution
Distribution scope not specified by the agency.
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