Agency classClass IIOur severity:Severe FDA (Drugs)·D-0207-2020·Announced 2019-11-13

Red Mountain Compounding Recalls Calcium Gluconate Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-Calcium Gluconate 10% Injection 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 severity rubric, an FDA Class II recall involving a medication with a sterility defect (which implies a risk of infection or hospitalization) falls under the 'Severe' category (Score 4), as it is not a Class I recall but involves a significant health risk.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Calcium Gluconate 10% Injection (PF) packaged in 10 ml and 5 ml glass vials. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected products were distributed nationwide in the USA. The recall includes 18 vials of 10 ml and 1 vial of 5 ml. Specific lot numbers and expiration dates are listed in the official recall notice, including lots expiring between September 2019 and January 2020.

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

The recalled product

Product: S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility
infection-risk

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 (15)

Lot #: a) 03072019DH@08
Exp 9/7/19
S04042019DT@04
Exp 10/4/19
S05012019DH@04
Exp 11/1/19
S05242019DT@12
Exp 11/24/19
S06182019DH@12 Exp 12/18/19
S06182019DH@32
Exp 12/18/19
S07152019DH@02
Exp 1/15/20
b) S06202019DT@05
Exp 12/20/19

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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