Recall Enforment Report D-0099-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 08-06-2018 for the product Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01 The product was recalled due to defective delivery system: there is a potential for some tablets to be missing the laser drilling which might affect drug release.. The product was distributed in Product Was Distributed Throughout The United States. Bulk Product Was Distributed To Takeda, Deerfield, Il And May Have Been Further Distributed. 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-0099-201908-06-201810-31-2018Class II3,397 bottlesMetformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated
D-0096-201908-06-201810-31-2018Class II27,816 bottlesPaliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated
D-0100-201908-06-201810-31-2018Class II82,291 bottlesMetformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated
D-0101-201908-06-201810-31-2018Class IIN/AMetformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated
D-0097-201908-06-201810-31-2018Class II3,785 bottlesPaliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated
D-0102-201908-06-201810-31-2018Class IIN/APIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated
D-0098-201908-06-201810-31-2018Class II13,225 bottlesFortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0591-3692Paliperidone PaliperidoneTablet, Film Coated, Extended ReleaseOralActavis Pharma, Inc.Human Prescription Drug
0591-3693Paliperidone Actavis Pharma, Inc.
0591-3694Paliperidone Actavis Pharma, Inc.
0591-3695Paliperidone Actavis Pharma, Inc.
59630-574Fortamet Metformin HydrochlorideTablet, Film Coated, Extended ReleaseOralShionogi Inc.Human Prescription Drug
59630-575Fortamet Metformin HydrochlorideTablet, Film Coated, Extended ReleaseOralShionogi Inc.Human Prescription Drug