Atrapro Antipruritic Hydrogel — Class II medical device recall Z-0890-2013

Terminated recall by Oculus Innovative Sciences Inc, reported 2013-03-06, distributed nationwide. Out of specification result - stability test failure of free available chlorine (FAC) which functions as a pre

Recall number	`Z-0890-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Oculus Innovative Sciences Inc, Petaluma, CA, United States
Recall initiated	2013-02-12
Classified	2013-02-26
Reported by FDA	2013-03-06
Terminated	2013-11-25
Distributed	Nationwide (US)
Quantity	56,566
Reason classes	specification failure
Lot numbers	`12A0012`, `12A0013`, `12A1116`, `12A1119`, `12B1144`, `12B1148`, `12C1157`, `12E190`, `12E194`, `12E198`, `12E202`, `12E208`, `12E211`
Expiration dates	`2013-02`, `2013-03`, `2013-04`, `2013-06`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0890-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.