Amneal issues nationwide voluntary recall of Vancomycin Hydrochloride for Oral Solution 250 mg/5 mL
Amneal is voluntarily recalling four lots of Vancomycin Hydrochloride for Oral Solution, 250 mg/5 mL packaged in 80 mL, 150 mL or 300 mL pack sizes, to the consumer level. Some bottles may have been overfilled which can result in an over potent dosing regimen, Amneal said.
The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10 mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing, Amneal said.
Amneal proivided the following risk statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5 mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
[Read more: Amneal debuts 2 generics]
Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.
The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.
Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL
| 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 |
The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed nationwide in the U.S. directly to wholesalers and distributors. The Lots were distributed between 11/09/2023 and 2/20/2024.
Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of the recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately.
Customers who purchased the impacted product directly from Amneal may call Amneal at 1 833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email to [email protected] for further information.
Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots and contact Amneal directly via email at [email protected] or by telephone 1833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, for information and instructions for the product return.
Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1 833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email [email protected] for further information and instructions for the product return. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at [email protected].
Any 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: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.