Agency classClass IIOur severity:Severe FDA (Drugs)·D-0224-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Glutathione Vials Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-Glutathione 200mg/mL vials due to a lack of assurance of sterility.

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, an FDA Class II recall involving a significant hazard such as lack of sterility in a medical product corresponds to a 'Severe' severity score of 4.

Plain-English summary

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling S-Glutathione 200mg/mL MDV packaged in 12 mL and 30 mL glass vials. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected products were distributed nationwide in the USA. The recall includes 2 vials of 12 mL and 79 vials of 30 mL. Specific lot numbers and expiration dates are listed in the official recall notice, including lots such as S06252019DH@12 and S05162019DH@19.

Consumers who have these specific products should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product: S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility

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 (20)

Lot #: a) S06252019DH@12
Exp 9/25/19
S07162019DT@02
Exp 10/16/19
b) S05162019DH@19
Exp 8/16/19
S05072019DT@08
Exp 8/7/19
S05082019DT@07
Exp 8/8/19
S05282019DT@08
Exp 8/28/19
S05312019DT@05
Exp 8/31/19
S06182019DH@11
Exp 9/18/19
S06242019DH@09
Exp 9/24/19
S07102019DT@06
Exp 10/10/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding 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 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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