Massive Recall of IV Drugs - MedWaste Management Massive Recall of IV Drugs - MedWaste Management

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FDA Recall Leiters IV medications

Massive Recall of IV Drugs

The FDA has announced a massive recall of several IV medications due to the possibility that they contain twice the listed dosage within the bag. Leiters Health is voluntarily cooperating with the recall after detecting an issue with the equipment used to fill the IV bags in 33 lots. Some of the drugs, particularly Fentanyl, may be fatal at the super potent doses. All medical facilities and pharmacies are urged to immediately inspect their inventory and remove all stock affected by the recall.

As of the writing of this notice, the FDA has not received any reports of adverse events related to the improperly dosed batch of medications.

SUMMARY

Date of Recall:

Announced: January 5, 2024

Public Notification: January 8, 2024

Name(s) of Drug:

Numerous Drugs Affected

Company Name:

Leiters HEalth

Brand Name:

Leiters, Compounding Health

Drug Indication:

Several indications

Leiters fentaNYL FDA Recall Label Leiters fentaNYL FDA Recall Label Leiters PHENYLephrine FDA Recall Label Leiters PHENYLephrine FDA Recall Label Leiters Vancomycin FDA Recall Label Leiters Vancomycin FDA Recall Label

Product Description

Health systems nationwide received distributions of medication. The medications were in prepared IV bags and clearly labeled with the drug name and intended dosage. All three drugs were contained within a bag of 0.9% Sodium Chloride in either a 100mL or 250mL bag.

Reason for Recall

Inspectors noted a defect in the machine responsible for distributing the drug into the solution. The defective machine may have resulted in up to double the dose of the medication being inserted into the bag. Without testing the solution, there is no way to know if it is properly dosed. Therefore, the manufacturer is voluntarily recalling the affected lots.

Impacts

These drugs are extremely dangerous when not dosed properly, and each poses a threat in its own way. For instance, patients who receive a higher-than-intended dose of Vancomycin may experience life-threatening adverse events such as:

  • Low blood pressure
  • Shock
  • Cardiac arrest
  • Wheezing
  • Shortness of breath
  • Hives
  • Itchy skin
  • Acute kidney injury
  • Ototoxicity (hearing damage)
  • Death

Similarly, patients who receive a higher-than-intended dose of Fentanyl may experience life-threatening adverse events, including:

  • Respiratory depression (loss of breathing function)
  • Brain damage
  • Low blood pressure
  • Low heart rate
  • Cardiac arrest
  • Death

Patients who receive a higher-than-intended dose of Phenylephrine may experience life-threatening adverse events, including:

  • High blood pressure

Lot Information

All pharmacies and medical institutions are urged to inventory their stock for the presence of the recalled drugs. Compare existing stock with the product information in the chart below. Remove any stock that matches the drug name, strength, item number, lot number, and expiration date from circulation. Follow the recall procedures listed below.

Product Description
 
Item #
Lot #
Expiration Date

FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag

F3355

2331062

2/8/2024

2331224

3/18/2024

2331270

3/28/2024

FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag

F3342 233098 1/31/2024

2331058

2/18/2024

2331150

3/10/2024

2331231

3/24/2024

2331289

3/30/2024

Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to
0.9% Sodium Chloride 250 mL IV Bag

F3360

2330993

2/15/2024

2331010

2/10/2024

2331055

1/18/2024

2331113

2/26/2024

2331181

3/4/2024

2331187

3/23/2024

2331266

3/31/2024

2331343

4/1/2024

2331349

4/23/2024

2331433

5/5/2024

Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added
to 0.9% Sodium Chloride 250 mL IV Bag

F3352

2330939

1/30/2024

2331032

2/3/2024

2331112

3/19/2024

2331190

3/26/2024

2331429

4/28/2024

Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride
250 mL IV Bag

F3206

2331184

2/13/2024

2331185

2/10/2024

2331189

2/20/2024

2331191

2/24/2024

2331258

3/3/2024

2331317

3/15/2024

Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride
250 mL IV Bag

F3208

2331140

2/8/2024

2331188

2/15/2024

2331261

3/5/2024

2331287

3/14/2024

FDA.gov

Have you found that the medication in your stock is part of the recall? Here’s what you should do:

Health Systems

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Leiters Health at 1-800-292-6772 or recall@leiters.com for assistance.
  3. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Leiters Health at 1-800-292-6772 or recall@leiters.com for assistance.
  3. If you have additional questions, contact Pfizer Medical Information at 1 (800) 438-1985, option 3. They are available Monday-Friday from 9:00 a.m. to 5:00 p.m. ET. You may also contact them online at www.pfizermedinfo.com.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse and Healthcare Writer Byline Image

 

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug and alcohol, and hospice and palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!

 


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