Recall Z-0856-2022 ยท OLR Oral Wound Dressing
SA3, LLC
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
| Date | Feb 21, 2022 |
| Status | Terminated |
| Reason | Due to failure of microbial testing for total aerobic microbial count (TAMC). |
| Root cause | Under Investigation by firm |
| Action | On 02/21/2022, the firm emailed an Urgent Recall Notification to customers informing them that the recall has been initiated due to the affected lot's microbial testing results for total aerobic microbial count (TAMC exceeded specifications prior to expiry of the gel. Customer are instructed to: 1. Immediately examine your inventory and quarantine product subject to this recall. 2. Immediately discontinue use and distribution of the identified lot number. 3. To request a prepaid shipping label, complete and return the enclosed Customer Market Withdrawal Return Response Form via email at info |
| Quantity | 156 units |
| Distribution | U.S. Nationwide distribution in the states of CA, FL and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202000 | Silatrix Oral Gel Sa3, LLC, Nov 20, 2020 |