The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0953-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Glutathione Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Glutathione Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric. The hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Glutathione Injection, 200mg/mL. The recall is being conducted because the product lacks assurance of sterility. The affected product is a 30 mL multi-dose vial intended for intravenous (IV) and intramuscular (IM) use and requires refrigeration.

The recall includes three specific lots: 10212019+53138 (expiration date 11/19/2020), 10302019+53172 (expiration date 1/28/2020), and 11122019+53225 (expiration date 2/10/2020). The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If you have this product, do not use it and contact your healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable Medication
Hazard

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 (6)

  • Lot #: 10212019+53138
  • Exp 11/19/2020
  • 10302019+53172
  • Exp 1/28/2020
  • 11122019+53225
  • Exp 2/10/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 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 63 products in this recall →

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Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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