Talon Compounding Pharmacy IVME SUPER B Injectable Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling IVME SUPER B Injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class II recall. Lack of sterility assurance in an injectable product poses risk of serious infection or adverse health consequences, meeting the threshold for Severe (score 4) per the rubric criterion for FDA Class II recalls.
Plain-English summary
Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247, is recalling IVME SUPER B Injectable due to lack of assurance of sterility.
The affected product consists of 99 vials with the following lot numbers and beyond-use dates: Lot 07262021:54 (BUD 10/24/2021), Lot 07262021:04 (BUD 10/24/2021), Lot 09092021:07 (BUD 12/09/2021), Lot 09092021:97 (BUD 12/09/2021), and Lot 09102021:10 (BUD 12/09/2021).
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. This is a prescription-only injectable medication. Patients who have received doses of this product should consult their healthcare provider immediately. Healthcare providers should review patient records to identify potentially affected recipients.
The recalled product
- Product
- IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 99
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 (5)
- Lot: 07262021:54 BUD: 10/24/2021
- 07262021:04 BUD: 10/24/2021
- 09092021:07 BUD: 12/09/2021
- 09092021:97 BUD: 12/09/2021
- 09102021:10 BUD: 12/09/2021
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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