Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 1,000 MCG/mL injectable vials due to lack of assurance of sterility. The affected lot was distributed across the United States, including Washington, D.C. and Puerto Rico.
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 an injectable drug with a critical safety defect (lack of sterility assurance), which can lead to serious infections and potentially require hospitalization. Class II recalls of injectable pharmaceuticals meet the Severe threshold even without reported illnesses to date.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 1,000 MCG/mL Injectable, supplied in 1,000 MCG/mL vials, due to lack of assurance of sterility.
The recalled product is lot 09102021:19 with a beyond-use date of 11/09/2021. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Consumers who have received this medication should contact their healthcare provider for guidance. Healthcare providers who dispensed this product should review their records to identify affected patients and take appropriate action.
The recalled product
- Product
- HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 2
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: 09102021:19 BUD: 11/09/2021
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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