Agency classClass IIOur severity:Severe FDA (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.

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 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
Affected units: 23

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

Distributed in 2 states:

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.

See all 130 products in this recall →

Same manufacturer · Vita Pharmacy, LLC dba Talon Compounding Pharmacy

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