D-1676-2012 Class II Terminated
FDA drug recall D-1676-2012 was initiated by Dukal Corp. on June 14, 2012 and is designated Class II. Reason for recall: Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer) The recall status is terminated (terminated June 21, 2013).
Recall Details
- Product Type
- Drugs
- Report Date
- September 26, 2012
- Initiation Date
- June 14, 2012
- Termination Date
- June 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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
Reason for Recall
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Distribution Pattern
Nationwide
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