The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1662-2019·Announced 2019-08-14

RXQ Compounding Recalls Glutathione Injection Due to Sterility Concerns

RXQ Compounding LLC is recalling Glutathione 200mg/ml Injection Solution because the product lacks assurance of sterility. All lots within expiry are affected 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 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. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as infection from non-sterile injections) are rated as Severe (4), especially when the agency classification is explicitly Class II and the hazard involves a significant risk of harm.

Plain-English summary

RXQ Compounding LLC is recalling Glutathione 200mg/ml (PFV) Injection Solution, 10 ml per vial (NDC: 70731-0971-81). The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the United States, and all lots within their expiration dates are included in this recall.

The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The specific hazard is the lack of assurance of sterility, which poses a risk of infection if the product is administered.

Consumers and healthcare providers should stop using the recalled product immediately. Patients who have received the product should contact their healthcare provider for guidance. The recalling firm, RXQ Compounding LLC, is responsible for managing the recall and providing further information to affected parties.

The recalled product

Product
GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0971-81
Manufacturer
RXQ Compounding LLC
Category
Drug — Injectable Compounded 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 (1)

  • All lots within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by RXQ Compounding LLC 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 86 products in this recall →

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