The Recall Desk
SevereFDA (Drugs)·D-0149-2022·Announced 2021-11-17

Vitamin D3 Injectable from Talon Compounding Pharmacy Recalled for Sterility Assurance

Talon Compounding Pharmacy is recalling Vitamin D3 100,000 IU/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

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 for a compounded injectable drug with lack of sterility assurance. Per the rubric, FDA Class II recalls are typically scored as 2, but lack of sterility in injectable products represents a significant risk of infection and harm to patients, and the recall involves multiple lot numbers distributed nationwide, warranting a Severe (4) classification.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Vitamin D3 100,000 IU/mL Injectable (Rx only) due to lack of assurance of sterility. The recalled product was manufactured and distributed from Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico. A total of 23 vials were involved in this recall across multiple lot numbers with different beyond-use dates (BUDs).

Consumers and healthcare providers who have received this product should immediately discontinue use and contact Talon Compounding Pharmacy. Patients who have received injections of this product should consult with their healthcare provider regarding potential exposure to non-sterile compounded drugs.

The recalled product

Product
VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, 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 — Compounded Injectable / Vitamin
Hazard
  • sterility-assurance
  • injection-safety
  • 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 (5)

  • Lot: 05272021:20 BUD: 11/23/2021
  • 06142021:34 BUD: 12/11/2021
  • 08052021:18 BUD: 01/05/2022
  • 08192021:43 BUD: 01/05/2022
  • 03302021:15 BUD: 08/12/2021

Distribution

Distribution scope not specified by the agency.

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