Vancomycin HCl Injection Recall for Lack of Sterility Assurance
Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.
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 recall is classified as FDA Class II for a sterility defect in an injectable drug product. Lack of sterility assurance in intravenous medications presents a serious risk of infection and potential hospitalization, meeting the criteria for Severe severity.
Plain-English summary
Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free). The recall affects 1,795 pre-filled 250 mL bags, which were distributed nationwide. The product is identified by NDC 05446-1456-01.
The recall was initiated due to lack of assurance of sterility. Vancomycin is an antibiotic administered intravenously, and a loss of sterility assurance means the product may not be safe for injection.
The affected product was manufactured with lot codes 09-2021-13@3 with expiration date 12/27/2021 and 09-2021-30@5 with expiration date 01/13/2022. Consumers or healthcare providers who have received this product should not use it and should contact Edge Pharma, LLC for further instructions.
The recalled product
- Product
- Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Injectable Antibiotic
- Affected units
- 1,795
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)
- 09-2021-13@3 12/27/2021 & 09-2021-30@5 01/13/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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