Agency classClass IIOur severity:High FDA (Drugs)·D-0210-2023·Announced 2023-02-01

Glutathione Injectable and Inhalation Products Recalled Due to Sterility Assurance Failure

Pharmacy Innovations is recalling multiple glutathione products due to insanitary facility conditions that compromise sterility assurance. The recall affects inhalation and injectable formulations distributed nationwide.

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 for sterility failure in injectable and inhalation products due to insanitary facility conditions. No reported illnesses or hospitalizations; the hazard is a risk-of-harm scenario where preventative action was taken before injury occurred.

Plain-English summary

Pharmacy Innovations is recalling glutathione L-reduced products in multiple formulations, including inhalation nebulizers (100 mg/mL and 200 mg/mL) and injectable vials (220 mg/mL, 500 mg/mL single and double vials) due to lack of assurance of sterility.

An FDA inspection of the manufacturing facility in Erie, Pennsylvania revealed insanitary conditions that compromise the sterility of these products. Injectable and inhalation medications must be sterile to prevent serious infections and other complications.

These products have been distributed nationwide. Consumers using these products should discontinue use and consult their healthcare provider. Healthcare providers should identify and contact patients who may have received affected batches.

The recalled product

Product: GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE…
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable / Inhalation
Hazard: sterility-failure
contamination

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)

t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36

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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