Recall Z-0448-2012 ยท FRO Dressing, Wound, Drug
Oculus Innovative Sciences Inc
Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laborat
| Date | Jan 11, 2012 (initiated Nov 9, 2011) |
| Status | Terminated |
| Reason | Unapproved drug claims and those not approved under 510K clearance. |
| Root cause | Process control |
| Action | Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall. |
| Quantity | 1363 x 500 mL; 2037 x 990 mL. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |