Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceutica...
FDA Recall #D-1536-2022 — Class II — September 13, 2022
Product Description
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Reason for Recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,802 1000-count bottles
Distribution
Product was distributed to major distributors/wholesalers nationwide.
Code Information
Lot # Q201182, exp. date March 2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated