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Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syrin...

FDA Recall #D-0448-2022 — Class II — December 6, 2021

Recall #D-0448-2022 Date: December 6, 2021 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

CGMP Deviations

Recalling Firm

Edge Pharma, LLC — Colchester, VT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

6925 syringes

Distribution

nationwide

Code Information

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 .

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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