FDA recall D-0092-2018

Product

Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09

Reason for recall

Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.

Distribution

Product was distributed throughout the United States, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2017-11-29

Termination date

2019-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vasco Da Gama, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2018