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Recall Enforment Report D-1049-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Longbow First Aid Products Manufactory, originally initiated on 07-17-2018 for the product Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211. The product was recalled due to cgmp deviations. The product was distributed in Ny And Ca. and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1049-201807-17-201808-15-2018Class II14,400 bottlesEyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.CGMP DeviationsTerminated
D-1048-201807-17-201808-15-2018Class II30,000 bottlesEmergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NYCGMP DeviationsTerminated