Oculus Innovative Sciences Recalls Atrapro Antipruritic Hydrogel Due to Preservative Failure
Oculus Innovative Sciences is recalling Atrapro Antipruritic Hydrogel because stability testing showed insufficient free available chlorine, a preservative required to maintain product safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk related to preservative failure, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Oculus Innovative Sciences Inc is recalling 56,566 tubes of Atrapro Antipruritic Hydrogel, 1.5 oz. The product is a prescription-only professional sample intended to manage and relieve burning, itching, and pain associated with various dermatoses, including radiation dermatitis and atopic dermatitis.
The recall was initiated due to an out-of-specification result in stability testing. The product failed to meet the specification for free available chlorine (FAC), which functions as a preservative for the hydrogel. The 13-month stability test result showed 4 ppm FAC, while the required specification is greater than 10 ppm FAC.
The affected lots were distributed nationwide through one distributor in Pennsylvania. The specific lot numbers and expiration dates are: 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), and Lot 12E211 (Exp 6/2013). Consumers and healthcare providers should stop using the product and contact the manufacturer for instructions on return or disposal.
The recalled product
- 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…
- Manufacturer
- Oculus Innovative Sciences Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot 12A0012
- Exp 2/2013
- Lot 12A0013
- Exp 2/2013: Lot 12A1116
- Exp 2.2013
- Lot 12A1119
- Lot 12B1144
- Exp 3/2013
- Lot 12B1148
- Lot 12C1157
- Exp 4/2013
- Lot 12E190. Exp 6/2013
- Lot 12E194
- Exp 6/2013
- Lot 12E198
- Lot 12E202. Exp 6/2013
- Lot 12E208
- Lot 12E211
- Exp 6/2013.
Distribution
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