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Class II: temporary or reversible health riskTerminated

Sentara Enterprises ASCORBIC ACID 500MG/Syringe Recall

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only

Sentara Enterprises · Chesapeake, VA

Risk level
Class II
Reported by FDA
Feb 3, 2016
Recall ID
D-0627-2016
Check your lot numberHow we source this data

Summary

Sentara Enterprises recalled ASCORBIC ACID 500MG/Syringe starting Sep 18, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0627-2016 on Feb 3, 2016. Reason: Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Product description

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Lot numbers, UPCs & expiration codes

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15

Where it was sold

U.S. Including: VA, NC

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-0627-2016
Classification
Class II
Status
Terminated
Recall initiated
Sep 18, 2015
FDA report date
Feb 3, 2016
Quantity
7 Syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Sentara Enterprises

Original FDA data

Every field from FDA enforcement report D-0627-2016, exactly as published.

Show all FDA fields
City
Chesapeake
State
VA
Status
Terminated
Country
United States
Event ID
72746
Address
535 Independence Pkwy Ste 300
Code information
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15
Postal code
23320-5176
Report date
Feb 3, 2016
Product type
Drugs
Recall number
D-0627-2016
Classification
Class II
Recalling firm
Sentara Enterprises
Product quantity
7 Syringes
Termination date
Jun 29, 2016
Reason for recall
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Voluntary / mandated
Voluntary: Firm initiated
Product description
ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Distribution pattern
U.S. Including: VA, NC
Recall initiation date
Sep 18, 2015
Initial firm notification
E-Mail
Center classification date
Jan 28, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0627-2016, published Feb 3, 2016. 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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