Drug recall D-0457-2021

Class II Terminated reported Jun 2, 2021

Product

Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Lots and codes

3189866

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
52 bottles
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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