FDA recall D-0769-2022

Preferred Pharmaceuticals, Inc. · Class II · drug

Product

Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09

Reason for recall

Out of specification results observed in dissolution during long term stability testing.

Distribution

Nationwide in the USA and CA.

Key facts

Status
Terminated
Initiation date
2022-03-28
Report date
2022-04-20
Termination date
2022-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0769-2022