Agency classClass IIOur severity:Severe FDA (Drugs)·D-0258-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls Zinc Sulfate Solution Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of zinc sulfate solution because the FDA could not ensure the product was 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 22 vials of S-ZINC SULFATE !MG/ML MDV SOLN, 10ml glass vial. The recall is due to a lack of assurance of sterility. The affected product is prescription-only and was distributed nationwide in the USA.

The recall covers specific lots with expiration dates ranging from September 2019 to October 2019. The identified lot numbers are S06112019DH@13, S06162019DH@03, S06182019DH@08, S06242019DH@12, and S07162019DT@10.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.

The recalled product

Product: S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Medication
Hazard: 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 (10)

Lot # S06112019DH@13
Exp 9/11/19
S06162019DH@03
Exp 9/16/19
S06182019DH@08
Exp 9/18/19
S06242019DH@12
Exp 9/24/19
S07162019DT@10
Exp 10/16/19

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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