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Class II: temporary or reversible health riskTerminated

Baptist Health Medical Towers Pharmacy and Infusion Services Invanz 1 gram Add-Vantage in 100 mL 0 Recall

Invanz 1 gram Add-Vantage in 100 mL 0

Baptist Health Medical Towers Pharmacy and Infusion Services · Little Rock, AR

Risk level
Class II
Reported by FDA
Jun 8, 2016
Recall ID
D-0928-2016
Check your lot numberHow we source this data

Summary

Baptist Health Medical Towers Pharmacy and Infusion Services recalled Invanz 1 gram Add-Vantage in 100 mL 0 starting Apr 18, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0928-2016 on Jun 8, 2016. Reason: Lack of Sterility Assurance. Status: Terminated.

Why it was recalled

Lack of Sterility Assurance.

Product description

Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

Lot numbers, UPCs & expiration codes

All product remaining within expiry.

Where it was sold

Arkansas

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-0928-2016
Classification
Class II
Status
Terminated
Recall initiated
Apr 18, 2016
FDA report date
Jun 8, 2016
Quantity
24 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baptist Health Medical Towers Pharmacy and Infusion Services

Original FDA data

Every field from FDA enforcement report D-0928-2016, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
73899
Address
9601 Baptist Health Dr Ste 109
Code information
All product remaining within expiry.
Postal code
72205-6323
Report date
Jun 8, 2016
Product type
Drugs
Recall number
D-0928-2016
Classification
Class II
Recalling firm
Baptist Health Medical Towers Pharmacy and Infusion Services
Product quantity
24 bags
Termination date
Dec 23, 2016
Reason for recall
Lack of Sterility Assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Distribution pattern
Arkansas
Recall initiation date
Apr 18, 2016
Initial firm notification
Telephone
Center classification date
May 29, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0928-2016, published Jun 8, 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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