Elevated risk U.S. Food and Drug Administration

Leiters, Compounding Health Vancomycin IV Bags, Phenylephrine IV Bags recall: Potential for superpotent drug

Recall published 2+ years ago

Potential for superpotent drug

Leiters, Compounding Health Prescription & OTC drugs — recalled prescription & otc drugsLeiters, Compounding Health Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Leiters, Compounding Health Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Leiters, Compounding Health Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
January 5, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Leiters, Compounding Health
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

What the company announced

FOR IMMEDIATE RELEASE – January 5, 2024 – Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice.

  • Item #: F3355 · Product Description: FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag · Lot #: 2331062 · Expiration: 2/8/2024
  • Item #: 2331224 · Product Description: 3/18/2024
  • Item #: 2331270 · Product Description: 3/28/2024
  • Item #: F3342 · Product Description: FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag · Lot #: 2330988 · Expiration: 1/31/2024
  • Item #: 2331058 · Product Description: 2/18/2024
  • Item #: 2331150 · Product Description: 3/10/2024
  • Item #: 2331231 · Product Description: 3/24/2024
  • Item #: 2331289 · Product Description: 3/30/2024
  • Item #: F3360 · Product Description: Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag · Lot #: 2330993 · Expiration: 2/15/2024
  • Item #: 2331010 · Product Description: 2/10/2024
  • Item #: 2331055 · Product Description: 1/18/2024
  • Item #: 2331113 · Product Description: 2/26/2024
  • Item #: 2331181 · Product Description: 3/4/2024
  • Item #: 2331187 · Product Description: 3/23/2024
  • Item #: 2331266 · Product Description: 3/31/2024
  • Item #: 2331343 · Product Description: 4/1/2024
  • Item #: 2331349 · Product Description: 4/23/2024
  • Item #: 2331433 · Product Description: 5/5/2024
  • Item #: F3352 · Product Description: Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag · Lot #: 2330939 · Expiration: 1/30/2024
  • Item #: 2331032 · Product Description: 2/3/2024
  • Item #: 2331112 · Product Description: 3/19/2024
  • Item #: 2331190 · Product Description: 3/26/2024
  • Item #: 2331429 · Product Description: 4/28/2024
  • Item #: F3206 · Product Description: Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag · Lot #: 2331184 · Expiration: 2/13/2024
  • Item #: 2331185 · Product Description: 2/10/2024
  • Item #: 2331189 · Product Description: 2/20/2024
  • Item #: 2331191 · Product Description: 2/24/2024
  • Item #: 2331258 · Product Description: 3/3/2024
  • Item #: 2331317 · Product Description: 3/15/2024
  • Item #: F3208 · Product Description: Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag · Lot #: 2331140 · Expiration: 2/8/2024
  • Item #: 2331188 · Product Description: 2/15/2024
  • Item #: 2331261 · Product Description: 3/5/2024
  • Item #: 2331287 · Product Description: 3/14/2024

Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients.

To date, Leiters Health has not received any reports of adverse events related to this recall.

Fentanyl is an analgesic packaged in an IV bag under codes F3355 and F3342. Phenylephrine is used for perioperative hypotension, hypotension during anesthesia, and shock and is packaged in an IV bag under codes F3360 and F3352.

Vancomycin is used for endocarditis and staphylococcal infections and is packaged in an IV bag under codes F3206 and F3208.

The products were distributed nationwide to hospitals for administration in the hospital. Leiters Health has notified its customers by a letter sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have product which is being recalled should cease using it and return it to Leiters Health.

Consumers with questions regarding this recall can contact Leiters Health by phone at 1-800-292-6772 or e-mail at [email protected] Monday through Friday between 8:00 AM MST and 5:30 PM MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Customers will receive return shipping labels for phenylephrine and vancomycin returns via email from Leiters Health to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112. Customers will receive return shipping labels, along with a DEA Form 222, for fentanyl returns via mail from Leiters Health to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 35 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2331062
  • 2330988
  • 2330993
  • 2330939
  • 2331184
  • 2331140

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2/8/2024
  • 1/31/2024
  • 2/15/2024
  • 1/30/2024
  • 2/13/2024

Model or item number

On the rating label, the box or the instruction sheet.

  • F3355
  • 2331224
  • 2331270
  • F3342
  • 2331058
  • 2331150
  • 2331231
  • 2331289
  • F3360
  • 2331010
  • 2331055
  • 2331113
  • 2331181
  • 2331187
  • 2331266
  • 2331343
  • 2331349
  • 2331433
  • F3352
  • 2331032

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 mL
  • 250 mL
  • 20 mg
  • 40 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Leiters, Compounding Health — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  3. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  4. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Customers that have product which is being recalled should cease using it and return it to Leiters Health.

Company contact: Leiters Health — Consumers: Leiters Health, 1-800-292-6772, [email protected] — Media: Kari Cashmore, Vice President Marketing, (720) 414-7216

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Leiters, Compounding Health prescription & otc drugs recalled?

Potential for superpotent drug Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2331062, 2330988, 2330993; best-by date 2/8/2024 or 1/31/2024; model number F3355, 2331224, 2331270. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

The notice says: Customers that have product which is being recalled should cease using it and return it to Leiters Health.

Where was the recalled product sold?

It was distributed nationwide.

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