Drug product
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
D-1676-2012
Product summary
- Firm
- Dukal Corp.
- Event
- Event 62320
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1676-2012
Official wording
Reason: Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
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
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial contamination