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Class II: temporary or reversible health riskTerminated

Avella of Deer Valley Bevacizumab 1 Recall

Bevacizumab 1

Avella of Deer Valley, Inc. · Phoenix, AZ

Risk level
Class II
Reported by FDA
Sep 25, 2013
Recall ID
D-1058-2013
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Summary

Avella of Deer Valley recalled Bevacizumab 1 starting Sep 9, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1058-2013 on Sep 25, 2013. Reason: Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

Product description

Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684

Lot numbers, UPCs & expiration codes

12-20130508@179, Exp 11/3/2013

Where it was sold

Nationwide and Puerto Rico

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-1058-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 9, 2013
FDA report date
Sep 25, 2013
Quantity
750 units
Recall type
Voluntary: Firm initiated
Recalling firm
Avella of Deer Valley, Inc.

Original FDA data

Every field from FDA enforcement report D-1058-2013, exactly as published.

Show all FDA fields
City
Phoenix
State
AZ
Status
Terminated
Country
United States
Event ID
66210
Address
23620 N 20th Dr Ste 12
Code information
12-20130508@179, Exp 11/3/2013
Postal code
85085-0621
Report date
Sep 25, 2013
Product type
Drugs
Recall number
D-1058-2013
Classification
Class II
Recalling firm
Avella of Deer Valley, Inc.
Product quantity
750 units
Termination date
Oct 17, 2013
Reason for recall
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Sep 9, 2013
Initial firm notification
Press Release
Center classification date
Sep 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1058-2013, published Sep 25, 2013. 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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