TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only,...

FDA Drug Recall #D-0751-2017 — Class II — April 18, 2017

Recall Summary

Recall Number D-0751-2017
Classification Class II — Moderate risk
Date Initiated April 18, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Key Pharmacy and Compounding Center
Location Federal Way, WA
Product Type Drugs
Quantity 4 vials

Product Description

TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reason for Recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Distribution Pattern

Distributed nationwide in U.S.A., Australia and Canada.

Lot / Code Information

Lot # t12-12-2016@93, Exp 5/22/2017; t02-22-2017@93, Exp 8/2/2017

Other Recalls from Key Pharmacy and Compounding Center

Recall # Classification Product Date
D-0772-2017 Class II PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Inj... Apr 18, 2017
D-0755-2017 Class II QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/... Apr 18, 2017
D-0758-2017 Class II ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injecti... Apr 18, 2017
D-0779-2017 Class II SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, ... Apr 18, 2017
D-0786-2017 Class II VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, In... Apr 18, 2017

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.