FDA Issues Recall for Commonly Prescribed Antibiotic - MedWaste Management FDA Issues Recall for Commonly Prescribed Antibiotic - MedWaste Management

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FDA Recall Vancomycin Antibiotic

FDA Issues Recall for Commonly Prescribed Antibiotic

The FDA has announced an urgent recall of the commonly prescribed antibiotic, Vancomycin. Four specific lots of the medication may have been overfilled during the manufacturing process, causing a higher-than-intended dose to be administered. Patients receiving an overdose of the medication are at risk of sustaining kidney damage as a result.

All medical facilities that administer the medication must check their stock carefully and remove any affected drugs. Patients must also check their current medication bottles to confirm if they are included in the recall.

As of the writing of this notice, the FDA has not released any information regarding adverse events related to this recall.

SUMMARY

Date of Recall:

Announced: March 27, 2024

Public Notification: March 27, 2024

Name(s) of Drug:

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL

Company Name:

Amneal Pharmaceuticals, LLC

Drug Indication:

Enterocolitis caused by Staphylococcus aureus

Pseudomembranous colitis caused by C. Difficile

FDA Recall Vancomycin Antibiotic label FDA Recall Vancomycin Antibiotic label FDA Recall Vancomycin Antibiotic label

Product Description

Vancomycin Hydrochloride is distributed by pharmacies nationwide. It is available by prescription only. Each bottle contains an NDC number, lot number, and expiration date. 80 mL, 150 mL, and 300 mL pack sizes are included in the recall.

Reason for Recall

During an inspection of the manufacturing process, it was determined that some bottles may have been overfilled, causing patients to receive a higher dose than intended. In some instances, patients may receive higher than the recommended total daily dose, leading to a high risk of kidney damage.

Impacts

Consumers who ingest medication that is included in the recall may experience symptoms related to kidney damage, including (but not limited to):

  • Decreased Urination
  • Edema (swelling)
  • High Blood Pressure
  • Shortness of Breath
  • Confusion
  • Fatigue
  • Nausea
  • Weakness
  • Irregular Heart Rate
  • Chest Pain
  • Seizures

Recall Lot Information

Healthcare facilities and consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL should compare their drug’s identifying information with that of the chart below. If you find that you are in possession of affected stock, see below for instructions on complying with the FDA recall.

NDC No.
Lot
Expiration Date
Pack Size
69238-2261-3 22613003A 09/2025 80 mL
69238-2261-7 22613004A 09/2025 150 mL
69238-2261-7 22613005A 09/2025 150 mL
69238-2261-5 22613005B 09/2025 300 mL

FDA.gov

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

Consumers

  1. If you believe you have ingested too high of a dose of the medication, call your physician immediately.
  2. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
  3. Continue to monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  4. Consumers who experience an adverse event should contact Amneal at 1-833-582-0812. They are available Monday through Friday from 8:00 a.m. to 5:00 p.m. (EST). You can also email them at Vancomycin_Recall@amneal.com.
  5. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  6. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Amneal at 1-833-582-0812, or you can utilize Vacomycin_Recall@amneal.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. 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 Amneal at 1-833-582-0812, or you can utilize Vacomycin_Recall@amneal.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & 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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