MIC/B Complex/Chrom/Carn/Lido Injectable Lacks Sterility Assurance
Talon Compounding Pharmacy is recalling one lot of MIC/B Complex/Chrom/Carn/Lido Injectable (Lot 07292021:73, BUD 10/30/2021) distributed nationwide due to lack of assurance of sterility. Patients who received this injectable product should consult their healthcare provider.
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: This is an FDA Class II recall of a sterile injectable product. Lack of sterility assurance in injectable pharmaceuticals poses a serious risk of infection and potential hospitalization, meeting the threshold for Severe (score 4) under the rubric criteria for Class II recalls with significant risk of harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE (Rx only) due to a lack of assurance of sterility.
The affected product is Lot 07292021:73 with a beyond-use date of 10/30/2021, distributed in the United States including Washington, D.C. and Puerto Rico. The product was manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
Patients who have received this injectable product should contact their healthcare provider immediately for evaluation and guidance regarding potential exposure to non-sterile injectable material.
The recalled product
- Product
- MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 1
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 (1)
- Lot: 07292021:73 BUD: 10/30/2021
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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