FDA-Drug2022-01-19Class II

Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00

Rubicon Research Private Limited
Hazard

Complaint received of foreign matter (metal) embedded in tablet.

Sold states
Product was distributed to one distributor who may have distributed the product further nationwide.
Affected count
3,684 1000-count bottles
Manufactured in
4 & K 30 5 Plot No K 30, N/A, Ambernath, N/A, India
Products
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0362-2022

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