Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a co...

FDA Drug Recall #D-0142-2018 — Class II — August 10, 2017

Recall Summary

Recall Number D-0142-2018
Classification Class II — Moderate risk
Date Initiated August 10, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SSM Health Care St. Louis DBA SSM St. Clare Health Center
Location Fenton, MO
Product Type Drugs
Quantity N/A

Product Description

Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01

Reason for Recall

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Distribution Pattern

SSM Health entities in the state of MO only

Lot / Code Information

Lot, exp: 170614-007, 9/12/2017; 170628-001, 9/26/2017; 170703-017, 10/1/2017; 170706-009, 10/4/2017; 170719-007, 10/17/2017

Other Recalls from SSM Health Care St. Louis DBA SSM St....

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D-0436-2024 Class II FentaNYL citrate, 10 mcg in 0.9% Sodium Chlorid... Feb 29, 2024
D-0435-2024 Class II Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total ... Feb 29, 2024
D-0776-2023 Class II HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridg... May 9, 2023
D-0007-2022 Class II Potassium Chloride 40 mEq in 0.9% Sodium Chlori... Sep 22, 2021
D-0139-2018 Class II HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 ... Aug 10, 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.