NDC 82804-007
methylprednisolone 4 mg tablet
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-916.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels it
Recalls
- May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20 - May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: 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… - May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20 - May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20. - May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Methylprednisolone: every company that makes it
- Form
- tablet, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA206751
- On the market since
- May 1, 2018
- Package NDCs
82804-007-2182804-007-3082804-007-6082804-007-90- Official label
- DailyMed (National Library of Medicine), updated Sep 1, 2023
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