Hydroxocobalamin 5,000 MCG/ML Injectable Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 5,000 MCG/ML Injectable due to lack of assurance of sterility. The affected lot is 08242021:51 with a BUD of 10/23/2021.
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 sterile injectable product with a deficiency in sterility assurance, which presents a risk of harm to patients who could receive a non-sterile injection. The source text does not report any illnesses or injuries, so the theoretical hazard qualifies as High (3) under the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 5,000 MCG/ML Injectable, a prescription injectable drug supplied in 1-vial units, due to a lack of assurance of sterility.
The recalled product is distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lot number is 08242021:51, with a beyond-use date (BUD) of 10/23/2021.
Patients who have received this product should consult their healthcare provider. Healthcare providers and patients with questions should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
The recalled product
- Product
- HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML 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
- 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 (1)
- Lot: 08242021:51 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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