The Recall Desk
ModerateFDA (Drugs)·D-0445-2022·Announced 2022-02-02

Vitamin K Oral Solution Recalled for CGMP Deviations

Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.

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 source classifies this as FDA Class II with no reported illnesses or injuries. The hazard is manufacturing process deviations (CGMP non-compliance) rather than confirmed contamination or a known risk of harm. Per the rubric, Class II recalls without hospitalization reports typically score 2 (Moderate).

Plain-English summary

Edge Pharma, LLC is recalling Vitamin K (Vitamin K) Oral Solution (PF), 5 mg/mL, supplied in 1 mL per syringe single-dose syringes for oral use. A total of 757 syringes have been distributed nationwide. The product is manufactured by Edge Pharma, LLC, located at 856 Hercules Drive, Colchester, Vermont.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations identified during the manufacturing process. This is a voluntary recall initiated by the firm, with the FDA classifying it as a Class II recall. The recall was reported on February 2, 2022, and the recall initiation date was December 6, 2021.

Affected lots were distributed between October 27, 2021 and December 1, 2021, with specific lot codes 10-2021-11@6 (dated 01-09-2022, distribution period 10/27/21 - 11/16/21) and 11-2021-01@8 (dated 01-30-2022, distribution period 11/16/21 - 12/01/21). The product is identified by NDC 05446-1132-03. Patients and healthcare providers should contact Edge Pharma, LLC or their pharmacy regarding this recall. The recall has been terminated as of June 7, 2023.

The recalled product

Product
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
Manufacturer
Edge Pharma, LLC
Category
Drug — Vitamin / Nutritional
Hazard
  • cgmp-deviation
  • manufacturing-compliance

Distribution

Distributed nationwide across the United States.

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