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Recall Observatory FDA recall evidence

Drug product

glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10

D-0491-2017

January 19, 2017

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
Event
Event 76291
Status
Terminated
Classification
Class II
Quantity
1338 bottles
Official record key
drug-enforcement:D-0491-2017

Official wording

Reason: Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets

Code information: Batch # 3074621, June 2018

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets