← FDA ENFORCEMENT
D-0517-2024Class II

Rubicon Research Private Limited

Recalling firm
Rubicon Research Private Limited
Product type
Drug
Status
Ongoing
Report date
2024-06-05
Distribution
Nationwide
Product quantity
11,664 Bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Presence of Foreign Substance: metal in tablet

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

Code / lot info

Lot 231037H1, exp 6/2027

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.