Reported Mar 6, 2013 · Terminated
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale.…
Oculus Innovative Sciences Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oculus Innovative Sciences Inc · 1129 N Mcdowell Blvd · Petaluma, CA · 94954-1110
Is this the product you have?
- Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale
- Pre-printed tubeMS31071
- Shelf cartonPL51091-08 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
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Lot 12A1116, Exp 2.2013 2 Lot 12A1119, Exp 2/2013 3 Lot 12B1144, Exp 3/2013 4 Lot 12B1148, Exp 3/2013 5 Lot 12C1157, Exp 4/2013 6 Lot 12E190. Exp 6/2013 7 Lot 12E194, Exp 6/2013 8 Lot 12E198, Exp 6/2013 9 Lot 12E202. Exp 6/2013 10 Lot 12E208, Exp 6/2013 11 Lot 12E211, Exp 6/2013. - Amount recalled
- 56,566 1.5 oz tubes
Where it was sold
- Nationwide
- PA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Oculus Innovative Sciences Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.