Recall Enforment Report D-1441-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Zydus Pharmaceuticals USA Inc, originally initiated on 05-06-2019 for the product Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10 The product was recalled due to cgmp deviations: cross contamination with other products due to cgmp cleaning failure.. 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-1441-201905-06-201906-26-2019Class II768 1000-count bottlesAnastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1453-201905-06-201906-26-2019Class II40872 25-count bottlesMethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1440-201905-06-201906-26-2019Class II1,425,264 30-count bottlesANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1451-201905-06-201906-26-2019Class II13,564 25-count bottlesMethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1448-201905-06-201906-26-2019Class II34521 100-count bottlesMethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1447-201905-06-201906-26-2019Class II113,304 90-count bottlesPramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1446-201905-06-201906-26-2019Class II168,330 90-count bottlesPramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1450-201905-06-201906-26-2019Class IIN/AMethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1449-201905-06-201906-26-2019Class IIN/AMethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1444-201905-06-201906-26-2019Class II215,760 90-count bottlesPramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1443-201905-06-201906-26-2019Class II143,184 90-count bottlesPramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1452-201905-06-201906-26-2019Class II47,664 90-count bottlesPramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1445-201905-06-201906-26-2019Class II3,156 1000-count bottlesPramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated
D-1442-201905-06-201906-26-2019Class II204 1000-count bottlesPramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68382-196Pramipexole Dihydrochloride Pramipexole DihydrochlorideTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-197Pramipexole Dihydrochloride Pramipexole DihydrochlorideTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-198Pramipexole Dihydrochloride Pramipexole DihydrochlorideTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-199Pramipexole Dihydrochloride Pramipexole DihydrochlorideTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-200Pramipexole Dihydrochloride Pramipexole DihydrochlorideTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-209Anastrozole AnastrozoleTablet, CoatedOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-440Pramipexole Dihydrochloride Pramipexole DihydrochlorideTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-916Methylprednisolone MethylprednisoloneTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-917Methylprednisolone MethylprednisoloneTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-918Methylprednisolone MethylprednisoloneTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug
68382-919Methylprednisolone MethylprednisoloneTabletOralZydus Pharmaceuticals Usa Inc.Human Prescription Drug