The Recall Desk
SevereFDA (Drugs)·D-0427-2022·Announced 2022-02-02

Vancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns

Edge Pharma is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects approximately 749 bags distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of an injectable drug. Lack of sterility assurance in a preservative-free intravenous medication presents a significant risk of serious infection in vulnerable patients, meeting the criterion for Severe severity.

Plain-English summary

Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bags due to lack of assurance of sterility. The affected product is manufactured by Edge Pharma, LLC, located at 856 Hercules Dr., Colchester, VT 05446, with NDC 05446-1459-01.

Approximately 749 bags are subject to this recall. The affected product lots are 09-2021-09@6 with expiration date 12/23/2021 and 10-2021-13@5 with expiration date 01/27/2022. The product was distributed nationwide.

Vancomycin is an intravenous antibiotic used to treat serious bacterial infections. Compromised sterility in an injectable medication could result in serious infection if administered to patients. Patients who have received this product should consult their healthcare provider. Healthcare providers and patients in possession of affected product should not use it and should contact their pharmacy or healthcare facility for proper handling and disposal.

The recalled product

Product
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Intravenous Injection
Hazard
  • lack-of-sterility
  • infection-risk
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 09-2021-09@6 12/23/2021 & 10-2021-13@5 01/27/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category