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Recall Observatory FDA recall evidence

Drug product

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.

D-0009-2015

July 03, 2014

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
Event
Event 68783
Status
Terminated
Classification
Class II
Quantity
15,966 bottles
Official record key
drug-enforcement:D-0009-2015

Official wording

Reason: Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Code information: Lot 3023805 Exp. 11/15

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets