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D-0188-2024Class II

CARDINAL HEALTHCARE

Recalling firm
CARDINAL HEALTHCARE
Product type
Drug
Status
Terminated
Report date
2024-01-03
Distribution
Nationwide USA
Firm state
OH
Product quantity
2 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Product description

Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01

Code / lot info

Batch Q101699, Q101981

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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.