The Recall Desk
HighFDA (Drugs)·D-0119-2023·Announced 2023-01-18

Methylcobalamin Injection Recalled Due to Lack of Sterility Assurance

Northern VA Compounders PLLC is recalling Methylcobalamin Injection Solution (12.5mg/ml, 2 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of an injectable product with lack of sterility assurance represents a risk-of-harm product. No illnesses or injuries have been reported, placing severity at High per rubric criteria.

Plain-English summary

Northern VA Compounders PLLC is recalling Methylcobalamin Injection Solution (12.5mg/ml, 2 mL vials) due to lack of assurance of sterility. The affected lot (Lot#: 11292022@16, expiration 1/13/2023) was compounded by Akina Pharmacy in Sterling, Virginia, and distributed nationwide.

The manufacturer could not guarantee that this lot met required sterility standards. Methylcobalamin is an injectable medication administered by healthcare providers.

Healthcare providers and patients who may have received this product should consult with their healthcare provider about any concerns regarding its use.

The recalled product

Product
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Manufacturer
Northern VA Compounders PLLC
Category
Drug — Compounded Injectable
Hazard
  • sterility-failure

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 (2)

  • Lot#: 11292022@16
  • Exp 1/13/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category