FDA Device recall Z-0890-2013
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale by Oculus Innovative Sciences, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0890-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-12 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Oculus Innovative Sciences |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/…Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/2013; Lot 12B1148, Exp 3/2013; Lot 12C1157, Exp 4/2013; Lot 12E190. Exp 6/2013; Lot 12E194, Exp 6/2013; Lot 12E198, Exp 6/2013; Lot 12E202. Exp 6/2013; Lot 12E208, Exp 6/2013; Lot 12E211, Exp 6/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0890-2013%22
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