Methylcobalamin Injectable Recalled for Sterility Assurance Failure
Talon Compounding Pharmacy is recalling 324 vials of Methylcobalamin 1MG/ML injectable across the United States and Puerto Rico due to lack of assurance of sterility.
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. Lack of sterility assurance in injectable medications presents a serious risk of infection and harm; such recalls meet the Severe threshold even without reported illnesses to date.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Methylcobalamin 1MG/ML (1000MCG/ML) Injectable, an Rx-only medication distributed from their San Antonio, Texas facility. The recall affects 324 vials across the United States including Washington, D.C. and Puerto Rico.
The recall is due to lack of assurance of sterility. The affected lots include: 07292021:79 (BUD 10/27/2021); 09072021:33 (BUD 12/07/2021); 09072021:32 (BUD 12/07/2021); 08312021:30 (BUD 11/29/2021); 07222021:66 (BUD 10/20/2021); 08242021:10 (BUD 11/22/2021); 07262021:12 (BUD 10/24/2021); 08182021:08 (BUD 11/16/2021); 09072021:31 (BUD 12/07/2021); 09092021:32 (BUD 12/08/2021); 09212021:12 (BUD 12/20/2021); and 09212021:88 (BUD 12/20/2021).
Healthcare providers and patients with vials from these lots should stop use immediately and consult with a healthcare professional about next steps.
The recalled product
- Product
- METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 324
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 (12)
- Lot: 07292021:79 BUD: 10/27/2021
- 09072021:33 BUD: 12/07/2021
- 09072021:32 BUD: 12/07/2021
- 08312021:30 BUD: 11/29/2021
- 07222021:66 BUD: 10/20/2021
- 08242021:10 BUD: 11/22/2021
- 07262021:12 BUD: 10/24/2021
- 08182021:08 BUD: 11/16/2021
- 09072021:31 BUD: 12/07/2021
- 09092021:32 BUD: 12/08/2021
- 09212021:12 BUD: 12/20/2021
- 09212021:88 BUD: 12/20/2021.
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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