Drug Enforcement D-0517-2024

Presence of Foreign Substance: metal in tablet

Status

Ongoing

Classification

Class II

Report Date

June 5, 2024

Termination Date

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Product Information

Product description
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Product quantity
11,664 Bottles
Reason for recall
Presence of Foreign Substance: metal in tablet
Recall initiation reason
—
Initial firm notification
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Distribution pattern
Nationwide

Location & Firm

Recalling firm
Rubicon Research Private Limited
Address
4 & K30 5 Plot No K - 30, District

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0517-2024
Event ID
94542
Recall initiation date
May 6, 2024
Center classification date
May 29, 2024
Code info
Lot 231037H1, exp 6/2027
More code info
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