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Recall Observatory FDA recall evidence

Drug product

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

D-0493-2017

January 27, 2017

Class II

Product summary

Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Event
Event 76463
Status
Terminated
Classification
Class II
Quantity
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Official record key
drug-enforcement:D-0493-2017

Official wording

Reason: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

Code information: Batch #3083289; Exp. Date 12/2018

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets