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Class II: temporary or reversible health riskTerminated

Guardian Pharmacy Services Ascorbic Acid 500 mg/mL 500 mL TPN Recall

Ascorbic Acid 500 mg/mL 500 mL TPN

Guardian Pharmacy Services · Dallas, TX

Risk level
Class II
Reported by FDA
Aug 15, 2018
Recall ID
D-1053-2018
Check your lot numberHow we source this data

Summary

Guardian Pharmacy Services recalled Ascorbic Acid 500 mg/mL 500 mL TPN starting May 17, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1053-2018 on Aug 15, 2018. Reason: Lack of sterility assurance. Status: Terminated.

Why it was recalled

Lack of sterility assurance.

Product description

Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Lot numbers, UPCs & expiration codes

Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018

Where it was sold

Texas

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-1053-2018
Classification
Class II
Status
Terminated
Recall initiated
May 17, 2018
FDA report date
Aug 15, 2018
Quantity
5000 500-ml bags
Recall type
Voluntary: Firm initiated
Recalling firm
Guardian Pharmacy Services

Original FDA data

Every field from FDA enforcement report D-1053-2018, exactly as published.

Show all FDA fields
City
Dallas
State
TX
Status
Terminated
Country
United States
Event ID
80118
Address
7920 Elmbrook Dr Ste 108
Code information
Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018
Postal code
75247-4933
Report date
Aug 15, 2018
Product type
Drugs
Recall number
D-1053-2018
Classification
Class II
Recalling firm
Guardian Pharmacy Services
Product quantity
5000 500-ml bags
Termination date
Nov 25, 2020
Reason for recall
Lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Distribution pattern
Texas
Recall initiation date
May 17, 2018
Initial firm notification
Letter
Center classification date
Aug 8, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1053-2018, published Aug 15, 2018. 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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