FDA recall D-1536-2022

Product

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.

Distribution

Product was distributed to major distributors/wholesalers nationwide.

Key facts

Status

Terminated

Initiation date

2022-09-13

Report date

2022-09-21

Termination date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1536-2022