Recall Enforment Report D-1025-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by West-Ward Columbus Inc, originally initiated on 07-24-2018 for the product Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05. The product was recalled due to failed dissolution specifications:. 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-1025-201807-24-201808-08-2018Class II29048 500-count bottles (14,524,000 tablets)Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.Failed Dissolution Specifications:Terminated
D-1024-201807-24-201808-08-2018Class II29,048 bottles (1,452,400 tablets)Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.Failed Dissolution Specifications:Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0143-2112Doxycycline Hyclate Doxycycline HyclateTablet, CoatedOralHikma Pharmaceuticals Usa Inc.Human Prescription Drug