Recall Enforment Report D-1032-2020

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Sun Pharmaceutical Industries, Inc., originally initiated on 03-13-2020 for the product Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. The product was recalled due to cgmp deviations: doxycycline capsules were not manufactured under current good manufacturing practice conditions.. The product was distributed nationwide 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-1032-202003-13-202003-25-2020Class II624 bottlesDoxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.Terminated
D-1033-202003-13-202003-25-2020Class II172,320 bottlesDoxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
63304-614Doxycycline DoxycyclineCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
63304-615Doxycycline DoxycyclineCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
63304-616Doxycycline DoxycyclineCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug