Agency classClass IIOur severity:Severe FDA (Drugs)·D-0093-2016·Announced 2015-11-04

FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns

FDA is recalling 2 syringes of injectable glutathione from Moses Lake Professional Pharmacy because the sterility of the compounded drug cannot be assured.

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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a structural or sterility defect in an injectable drug, which poses a risk of significant injury, is classified as Severe (Score 4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling two syringes of GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is being conducted because there is a lack of assurance of sterility for the sterile human compounded drugs within their expiry date.

The affected product is a prescription-only injectable solution. The recall covers two syringes with lot codes t03192015@31 and t04272015@5. The distribution pattern for this recall is listed as nationwide.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL syringe , Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Manufacturer: JD & SN Inc., dba Moses Lake Professional Pharmacy
Category: Drug — Injectable Solution
Hazard: sterility
infection
Affected units: 2

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)

t03192015@31
t04272015@5

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy 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 101 products in this recall →

Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy

See all →

Severe
FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Six Trimix Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2015-11-04

Same hazard · sterility