Methylprednisolone Tablet
FDA Recall NDC 68382-918
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Methylprednisolone (NDC 68382-918). A significant event, classified as Class II, was initiated on May 06, 2019 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
40872 25-count bottles
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
Batch or Lot Expiration Information
Lot# Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21
Affected Packages Involved in this Recall
68382-916-01Product
68382-916-05Product
68382-916-34Product
68382-917-11Product
68382-917-01Product
68382-917-05Product
68382-917-30Product
68382-917-77Product
68382-918-18Product
68382-918-01Product
68382-918-05Product
68382-918-30Product
68382-918-77Product
68382-919-11Product
68382-919-01Product
68382-919-05Product
68382-919-30Product
68382-919-77Product
Class II Terminated
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
13,564 25-count bottles
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
Batch or Lot Expiration Information
Lot# Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20.
Affected Packages Involved in this Recall
68382-916-01Product
68382-916-05Product
68382-916-34Product
68382-917-11Product
68382-917-01Product
68382-917-05Product
68382-917-30Product
68382-917-77Product
68382-918-18Product
68382-918-01Product
68382-918-05Product
68382-918-30Product
68382-918-77Product
68382-919-11Product
68382-919-01Product
68382-919-05Product
68382-919-30Product
68382-919-77Product
Class II Terminated
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
34521 100-count bottles
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01
Batch or Lot Expiration Information
Lot# Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20
Affected Packages Involved in this Recall
68382-916-01Product
68382-916-05Product
68382-916-34Product
68382-917-11Product
68382-917-01Product
68382-917-05Product
68382-917-30Product
68382-917-77Product
68382-918-18Product
68382-918-01Product
68382-918-05Product
68382-918-30Product
68382-918-77Product
68382-919-11Product
68382-919-01Product
68382-919-05Product
68382-919-30Product
68382-919-77Product
Class II Terminated
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
Batch or Lot Expiration Information
Lot# lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20
Affected Packages Involved in this Recall
68382-916-01Product
68382-916-05Product
68382-916-34Product
68382-917-11Product
68382-917-01Product
68382-917-05Product
68382-917-30Product
68382-917-77Product
68382-918-18Product
68382-918-01Product
68382-918-05Product
68382-918-30Product
68382-918-77Product
68382-919-11Product
68382-919-01Product
68382-919-05Product
68382-919-30Product
68382-919-77Product
Class II Terminated
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
Batch or Lot Expiration Information
Lot# Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21
Affected Packages Involved in this Recall
68382-916-01Product
68382-916-05Product
68382-916-34Product
68382-917-11Product
68382-917-01Product
68382-917-05Product
68382-917-30Product
68382-917-77Product
68382-918-18Product
68382-918-01Product
68382-918-05Product
68382-918-30Product
68382-918-77Product
68382-919-11Product
68382-919-01Product
68382-919-05Product
68382-919-30Product
68382-919-77Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
