Recall Z-0820-05 ยท LFD Saliva, Artificial
Kingswood Laboratories,Inc
Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.
| Date | May 11, 2005 (initiated Apr 22, 2005) |
| Status | Terminated |
| Reason | Contaminated with Aspergillus and Penicillum molds. |
| Root cause | Other |
| Action | The firm issued a press release on 4/22/05 instructing consumers to not use the product and to return it to them. Consignees were notified via letter dated 4/22/05. |
| Quantity | 3026 cases |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851026 | MOI-STIR ORAL SWABSTICK(S) Kingswood Laboratories, Inc., May 21, 1985 |