Oculus Innovative Sciences Inc: Medical Device Recall in 2013 - (Recall #: Z-0890-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 12, 2013

Date Posted: March 6, 2013

Recall Number: Z-0890-2013

Event ID: 64316

Reason for Recall:

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.

Status: Terminated

Product Quantity: 56,566 1.5 oz tubes

Code Information:

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.

Distribution Pattern:

Nationwide Distribution - One distributor in PA

Voluntary or Mandated:

Voluntary: Firm initiated