Methylcobalamin Injectable Recalled Due to Sterility Assurance Failure
Talon Compounding Pharmacy is recalling Methylcobalamin 5MG/ML injectable (Lot 07162021:70) distributed nationwide because the manufacturer cannot assure sterility of the product.
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 pharmaceutical product where sterility cannot be assured. Lack of sterility in injectable drugs poses significant risk of serious infection or adverse health consequences and meets the criterion for Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Methylcobalamin 5MG/ML (5000MCG/ML) injectable vials due to lack of assurance of sterility. The product is an Rx-only injectable preparation manufactured and distributed from the pharmacy's location in San Antonio, Texas.
The recall affects product with Lot number 07162021:70 (Beyond Use Date 10/14/2021) that was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers and healthcare providers who have received this product should not use it and should contact the recalling firm for instructions on return or destruction. Patients who have received injections from affected vials should consult their healthcare provider regarding potential exposure.
The recalled product
- Product
- METHYLCOBALAMIN 5MG/ML (5000MCG/ML) INJ 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- 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: 07162021:70 BUD: 10/14/2021
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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