Vancomycin HCl Oral Solution Recalled for CGMP Deviations
Edge Pharma is voluntarily recalling 6,925 syringes of Vancomycin HCl Oral Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II, and the source text documents CGMP deviations without reporting any illnesses, injuries, or confirmed product harm. This meets the criteria for a Moderate severity score: a voluntary precautionary recall based on manufacturing process deviations rather than confirmed safety incidents.
Plain-English summary
Edge Pharma, LLC is voluntarily recalling Vancomycin HCl Oral Solution (PF) 125 mg / 2.5 mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, manufactured in Colchester, Vermont, with NDC 05446-1348-01. A total of 6,925 syringes have been distributed nationwide.
The recall was initiated because Edge Pharma identified Current Good Manufacturing Practice (CGMP) deviations during manufacturing of the affected batches. The affected lot codes are: 09-2021-10@3 (dated 12-09-2021), 09-2021-17@6 (dated 12-16-2021), 09-2021-24@8 (dated 12-23-2021), 09-2021-30@7 (dated 12-29-2021), and 10-2021-13@6 (dated 01-11-2022).
This is a voluntary, firm-initiated Class II recall. Patients taking this medication should consult their healthcare provider or pharmacist about next steps. Healthcare providers should remove the affected lots from inventory and return them through their normal distribution channels.
The recalled product
- Product
- Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Oral Solution
- Affected units
- 6,925
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 (4)
- 09-2021-10@3 12-09-2021
- 09-2021-17@6 12-16-2021
- 09-2021-24@8 12-23-2021
- 09-2021-30@7 12-29-2021 & 10-2021-13@6 01-11-2022 .
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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