Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a hea
FDA device recall Z-0763-2017 · posted 2016-12-14 · Terminated
Recall details
- Recalling firm
- Oculus Innovative Sciences, Inc.
- Reason for recall
- Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
- Action taken
- Oculus issued Medical Device Recall letters dated November 21, 2016, to Sales reps notifying them to stop all further distribution and immediately remove the affected lots of Recall product from sample inventory. Customers were also instructed to sign the Response form verifying receipt of the letter. Customers with questions were instructed to call Oculus Innovative Science-Regulatory Affairs at 707-559-7181. For questions regarding this recall call 559-7191.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 68,970 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-11-21
- Date posted
- 2016-12-14
- Date terminated
- 2017-06-13
- Location
- Petaluma, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ceramax Skin Barrier Cream (K152055) | Oculus Innovative Sciences | 2015-11-23 |