The Recall Desk
SevereFDA (Drugs)·D-0125-2022·Announced 2021-11-17

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Injectable / Compounded Medication
Hazard
  • sterility-failure
  • 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 (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

Distribution scope not specified by the agency.

Related recalls

Same category