Agency classClass IIOur severity:Severe FDA (Drugs)·D-0293-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls S-Vit B Complex Injection Solution

Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection Solution 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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 46 30 mL glass vials of S-Vit B Complex Injection Solution. The recall is being conducted because the product lacks assurance of sterility.

The affected product is a prescription-only medication distributed nationwide in the USA. The recall covers specific lots with expiration dates ranging from August 10, 2019, to November 25, 2019.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Solution
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 (14)

Lot #:S04102019DT@09
Exp 8/10/19
S05012019DT@03
Exp 9/1/19
S05162019DH@21
Exp 9/16/19
S05152019DH@21
S06162019DH@14
Exp 10/16/19
S06262019DT@03
Exp 10/26/19
S06262019DT@10
S07252019DH@11
Exp 11/25/19

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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