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Class II: temporary or reversible health riskTerminated

Avella of Deer Valley Vancomycin PF Recall

Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684

Avella of Deer Valley, Inc. · Phoenix, AZ

Risk level
Class II
Reported by FDA
Sep 25, 2013
Recall ID
D-1059-2013
Check your lot numberHow we source this data

Summary

Avella of Deer Valley recalled Vancomycin PF starting Sep 9, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1059-2013 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

Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684

Lot numbers, UPCs & expiration codes

12-20130508@181, Exp 10/4/2013

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-1059-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 9, 2013
FDA report date
Sep 25, 2013
Quantity
250 units
Recall type
Voluntary: Firm initiated
Recalling firm
Avella of Deer Valley, Inc.

Original FDA data

Every field from FDA enforcement report D-1059-2013, 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@181, Exp 10/4/2013
Postal code
85085-0621
Report date
Sep 25, 2013
Product type
Drugs
Recall number
D-1059-2013
Classification
Class II
Recalling firm
Avella of Deer Valley, Inc.
Product quantity
250 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
Vancomycin PF (BSS) 1%, 1 mL, 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-1059-2013, published Sep 25, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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