Agency classClass IIOur severity:Severe FDA (Drugs)·D-0204-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-B5/B6/B12M Solution Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-B5/B6/B12M solution vials because the FDA cannot ensure the product is sterile.

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 and involves a lack of assurance of sterility in a medical product, which meets the rubric criteria for a Severe rating due to the potential for significant health consequences.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vials. The recall is being conducted because the U.S. Food and Drug Administration (FDA) has determined there is a lack of assurance of sterility for the product.

The affected product is prescription-only and was distributed nationwide in the USA. The recall includes specific lots with expiration dates ranging from August 2019 to October 2019. 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.

Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product: S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Injectable
Hazard: sterility
infection

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 (8)

Lot #: S05132019DH@02
Exp 8/13/19
S05142019DT@05
Exp 8/14/19
S07032019DT@10
Exp 10/3/19
S07182019DH@01
Exp 10/18/19

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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