The Recall Desk
SevereFDA (Drugs)·D-0426-2022·Announced 2022-02-02

Vancomycin HCl Injection Recalled for Sterility Assurance Issues

Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.

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: The FDA classified this as a Class II recall. Although the source text does not report specific illnesses or hospitalizations, the hazard of compromised sterility in an injectable drug represents significant potential for serious patient harm. Class II recalls by FDA policy warrant Severe (4) rating per the rubric.

Plain-English summary

Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, manufactured by Edge Pharma LLC in Colchester, VT (NDC 05446-1458-01). The recall involves 1,825 bags distributed nationwide.

The reason for the recall is lack of assurance of sterility. This is an FDA Class II recall, meaning the product may cause adverse health consequences or serious adverse effects, but is not expected to cause death.

Patients receiving this product should consult with their healthcare provider. Healthcare providers should discontinue use of the affected lots and contact their supplier or Edge Pharma LLC for instructions on return or disposal. The affected product codes are 08-2021-26@4 with date 12/08/2021 and 09-2021-21@3 with date 01/04/2022.

The recalled product

Product
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Injection / Injectable
Hazard
  • sterility-assurance
  • contamination-risk

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)

  • 08-2021-26@4 12/08/2021 & 09-2021-21@3 01/04/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category