FDA recall D-0511-2017

Product

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Reason for recall

Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.

Distribution

Nationwide in the United States and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-02-17

Report date

2017-03-15

Termination date

2018-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2017