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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64316
Product Type Devices
Status Ongoing
Recalling Firm Oculus Innovative Sciences Inc
City Petaluma
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-12
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern "Nationwide Distribution - One distributor in PA "

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 56,566 1.5 oz tubes Z-0890-2013
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