The Recall Desk
HighFDA (Drugs)·D-0122-2022·Announced 2021-11-17

L-Carnitine Injectable Injection Recalled for Sterility Concerns

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling L-Carnitine 250mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.

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 involving a sterility defect in an injectable pharmaceutical product. Although no illnesses or injuries are reported in the source text, the hazard—compromised sterility of an injectable drug—poses significant risk of serious harm. Injectables with sterility concerns create direct risk of infection and systemic complications, justifying a High severity rating.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling L-Carnitine 250mg/mL Injectable (Rx only) due to lack of assurance of sterility. The affected product consists of 4 vials with lot numbers 08172021:31 (BUD 11/15/2021) and 07152021:16 (BUD 10/13/2021).

The product was distributed to patients throughout the United States, including Washington, D.C. and Puerto Rico, from the pharmacy location at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

Patients currently using this product should consult their healthcare provider or pharmacist immediately regarding this recall. Healthcare providers who have distributed this product should contact affected patients and advise them of the recall. Questions about this recall may be directed to the FDA's Drug Recall Reporting and Evaluation system.

The recalled product

Product
L-CARNITINE 250MG/ML INJ 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 Pharmaceutical
Hazard
  • sterility-defect
  • microbial-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 (2)

  • Lot: 08172021:31 BUD: 11/15/2021
  • 07152021:16 BUD: 10/13/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category