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Class II: temporary or reversible health riskTerminated

Lincare Vancomycin 1 Recall

VANCOMYCIN 1

Lincare, Inc. · Little Rock, AR

Risk level
Class II
Reported by FDA
Jul 8, 2015
Recall ID
D-1171-2015
Check your lot numberHow we source this data

Summary

Lincare recalled Vancomycin 1 starting May 28, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1171-2015 on Jul 8, 2015. Reason: Lack of Assurance of Sterility: Sterility of product is not assured. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Sterility of product is not assured.

Product description

VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Lot numbers, UPCs & expiration codes

Compounded on 05/27/15, Discard After: 06/10/15

Where it was sold

United States including: 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-1171-2015
Classification
Class II
Status
Terminated
Recall initiated
May 28, 2015
FDA report date
Jul 8, 2015
Quantity
7 Bags
Recall type
Voluntary: Firm initiated
Recalling firm
Lincare, Inc.

Original FDA data

Every field from FDA enforcement report D-1171-2015, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
71415
Address
1527 S Bowman Rd Ste D
Code information
Compounded on 05/27/15, Discard After: 06/10/15
Postal code
72211-4200
Report date
Jul 8, 2015
Product type
Drugs
Recall number
D-1171-2015
Classification
Class II
Recalling firm
Lincare, Inc.
Product quantity
7 Bags
Termination date
Feb 16, 2017
Reason for recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Voluntary / mandated
Voluntary: Firm initiated
Product description
VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Distribution pattern
United States including: Arkansas
Recall initiation date
May 28, 2015
Initial firm notification
Telephone
Center classification date
Jul 1, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1171-2015, published Jul 8, 2015. 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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