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Class II: temporary or reversible health riskTerminated

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy S-Zinc Sulfate !Mg/Ml Mdv Soln Recall

S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · Mesa, AZ

Risk level
Class II
Reported by FDA
Nov 13, 2019
Recall ID
D-0258-2020
Check your lot numberHow we source this data

Summary

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalled S-Zinc Sulfate !Mg/Ml Mdv Soln starting Aug 12, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0258-2020 on Nov 13, 2019. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0258-2020
Classification
Class II
Status
Terminated
Recall initiated
Aug 12, 2019
FDA report date
Nov 13, 2019
Quantity
22x10 ml glass vial
Recall type
Voluntary: Firm initiated
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-0258-2020, exactly as published.

Show all FDA fields
City
Mesa
State
AZ
Status
Terminated
Country
United States
Event ID
83669
Address
6828 E Brown Rd Ste 101
Code information
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
Postal code
85207-3761
Report date
Nov 13, 2019
Product type
Drugs
Recall number
D-0258-2020
Classification
Class II
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Product quantity
22x10 ml glass vial
Termination date
Apr 13, 2023
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.
Distribution pattern
Nationwide in the USA
Recall initiation date
Aug 12, 2019
Initial firm notification
Letter
Center classification date
Nov 5, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0258-2020, published Nov 13, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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