D-0099-2019 | 08-06-2018 | 10-31-2018 | Class II | 3,397 bottles | 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 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |
D-0100-2019 | 08-06-2018 | 10-31-2018 | Class II | 82,291 bottles | Metformin 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 00591-2720-60 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |
D-0101-2019 | 08-06-2018 | 10-31-2018 | Class II | N/A | Metformin 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 00591-2412-19 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |
D-0098-2019 | 08-06-2018 | 10-31-2018 | Class II | 13,225 bottles | Fortamet (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 59630-575-60 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |
D-0102-2019 | 08-06-2018 | 10-31-2018 | Class II | N/A | PIO&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 60015 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |
D-0097-2019 | 08-06-2018 | 10-31-2018 | Class II | 3,785 bottles | Paliperidone 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 07054 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |
D-0096-2019 | 08-06-2018 | 10-31-2018 | Class II | 27,816 bottles | Paliperidone 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 07054 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Terminated |