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Class II: temporary or reversible health riskTerminated

Dukal Corporation BZK Swab Recall

Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0

Dukal Corp. · Ronkonkoma, NY

Risk level
Class II
Reported by FDA
Sep 26, 2012
Recall ID
D-1676-2012
Check your lot numberHow we source this data

Summary

Dukal recalled Dukal Corporation BZK Swab starting Jun 14, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1676-2012 on Sep 26, 2012. Reason: Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer). Status: Terminated.

Why it was recalled

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

Product description

Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031

Lot numbers, UPCs & expiration codes

Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711

Where it was sold

Nationwide

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-1676-2012
Classification
Class II
Status
Terminated
Recall initiated
Jun 14, 2012
FDA report date
Sep 26, 2012
Recall type
Voluntary: Firm initiated
Recalling firm
Dukal Corp.

Original FDA data

Every field from FDA enforcement report D-1676-2012, exactly as published.

Show all FDA fields
City
Ronkonkoma
State
NY
Status
Terminated
Country
United States
Event ID
62320
Address
2 Fleetwood Ct
Code information
Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711
Postal code
11779-6907
Report date
Sep 26, 2012
Product type
Drugs
Recall number
D-1676-2012
Classification
Class II
Recalling firm
Dukal Corp.
Termination date
Jun 21, 2013
Reason for recall
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031
Distribution pattern
Nationwide
Recall initiation date
Jun 14, 2012
Initial firm notification
E-Mail
Center classification date
Sep 17, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1676-2012, published Sep 26, 2012. 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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