Recall Z-0890-2013 ยท FRO Dressing, Wound, Drug
Oculus Innovative Sciences Inc
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.
| Date | Feb 26, 2013 (initiated Feb 12, 2013) |
| Status | Terminated |
| Reason | Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC. |
| Root cause | Incorrect or no expiration date |
| Action | Oculus sent an Urgent Medical Device Recall letter dated February 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue distribution and segregate the affected product. Immediately remove the affected lots of Recall product from the inventory of sales representative, sub contracted distribution and or fulfillment centers. Segregate the affected product in a secure location for return or destruction. If the product was further distributed customers were instructed |
| Quantity | 56,566 1.5 oz tubes |
| Distribution | Nationwide Distribution - One distributor in PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012945 | SYNTHES 2.4 MM CANNULATED SCREW Synthes (Usa), Dec 3, 2001 |