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Class II: temporary or reversible health riskTerminated

Family Pharmacy of Statesville Ketamine 50 mg Infusion Recall

Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Sta…

Family Pharmacy of Statesville · Statesville, NC

Risk level
Class II
Reported by FDA
Mar 23, 2022
Recall ID
D-0664-2022
Check your lot numberHow we source this data

Summary

Family Pharmacy of Statesville recalled Ketamine 50 mg Infusion starting Aug 6, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0664-2022 on Mar 23, 2022. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Lot numbers, UPCs & expiration codes

Lot #: 07212020@1 BUD: 8/4/2020; 07232020@2 BUD: 8/6/2020; 07302020@2 BUD: 8/13/2020

Where it was sold

NC only

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-0664-2022
Classification
Class II
Status
Terminated
Recall initiated
Aug 6, 2020
FDA report date
Mar 23, 2022
Quantity
3 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Family Pharmacy of Statesville

Original FDA data

Every field from FDA enforcement report D-0664-2022, exactly as published.

Show all FDA fields
City
Statesville
State
NC
Status
Terminated
Country
United States
Event ID
89773
Address
3478 E Broad St
Code information
Lot #: 07212020@1 BUD: 8/4/2020; 07232020@2 BUD: 8/6/2020; 07302020@2 BUD: 8/13/2020
Postal code
28625-4523
Report date
Mar 23, 2022
Product type
Drugs
Recall number
D-0664-2022
Classification
Class II
Recalling firm
Family Pharmacy of Statesville
Product quantity
3 bags
Termination date
Aug 15, 2023
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Distribution pattern
NC only
Recall initiation date
Aug 6, 2020
Initial firm notification
Telephone
Center classification date
Mar 17, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0664-2022, published Mar 23, 2022. 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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