IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 2...

FDA Drug Recall #D-0121-2022 — Class II — October 12, 2021

Recall Summary

Recall Number D-0121-2022
Classification Class II — Moderate risk
Date Initiated October 12, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Location San Antonio, TX
Product Type Drugs
Quantity 99 vials

Product Description

IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Reason for Recall

Lack of assurance of sterility

Distribution Pattern

United States including Washington, D.C. and Puerto Rico

Lot / Code Information

Lot: 07262021:54 BUD: 10/24/2021; 07262021:04 BUD: 10/24/2021; 09092021:07 BUD: 12/09/2021; 09092021:97 BUD: 12/09/2021; 09102021:10 BUD: 12/09/2021

Other Recalls from Vita Pharmacy, LLC dba Talon Compound...

Recall # Classification Product Date
D-0106-2022 Class II B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTA... Oct 12, 2021
D-0104-2022 Class II ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, ... Oct 12, 2021
D-0147-2022 Class II TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200... Oct 12, 2021
D-0159-2022 Class II TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERID... Oct 12, 2021
D-0148-2022 Class II ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 2... Oct 12, 2021

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.