Agency classClass IIOur severity:Severe FDA (Drugs)·D-0275-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-MIC Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/mL B12 1mg/mL MDV Injection Solution vials because of 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 108 vials of S-MIC 25/50/50mg/mL B12 1mg/mL MDV Injection Solution. The product is available in 10 mL and 30 mL glass vials and was distributed nationwide in the United States. The recall is being conducted due to a lack of assurance of sterility.

The affected lots include S03272019DT@04, S01302019DT@08, S02192019DH@10, S03072019DH@01, S03042019DH@02, S04172019DT@03, S04302019DT@11, S05162019DH@20, S05292019DT@03, S06252019DH@17, S07172019DT@12, and S07182019DT@08. These lots have expiration dates ranging from August 19, 2019, to January 18, 2020.

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

The recalled product

Product: S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 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 (20)

Lot #: a) S03272019DT@04
Exp 09/27/2019
b) S01302019DT@08
Exp 08/30/2019
S02192019DH@10
Exp 08/19/2019
S03072019DH@01
Exp 09/07/2019
S03042019DH@02
S03272019DT@04
S04172019DT@03
Exp 10/17/2019
S04302019DT@11
Exp 10/30/2019
S05162019DH@20
Exp 11/16/2019
S05292019DT@03
Exp 11/29/2019
S06252019DH@17
Exp 12/25/2019

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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