Agency classClass IIOur severity:High FDA (Drugs)·D-0187-2023·Announced 2023-02-01

Injectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure

Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 due to insanitary facility conditions compromising sterility assurance. No illnesses or injuries are reported. This represents a risk-of-harm product where the potential for contamination exists but has not resulted in confirmed adverse health events.

Plain-English summary

Pharmacy Innovations is recalling all lots of Hydroxocobalamin 25MG/ML injectable vials (2ML vials) distributed nationwide. This is a prescription-only injectable medication.

The recall was initiated following an FDA inspection that identified insanitary conditions at the manufacturing facility in Erie, Pennsylvania. These conditions compromised the assurance of product sterility, a critical requirement for injectable medications.

The affected product was distributed nationwide. Healthcare providers and patients may have received doses of this medication.

Patients and healthcare providers who have this medication should discontinue use and contact their pharmacy or Pharmacy Innovations for guidance on returns and appropriate alternatives.

The recalled product

Product: Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable / Sterile Preparations
Hazard: sterility-failure
contamination-risk

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)

t20221025@33

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations 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.

See all 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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