FDA-Drug2017-01-25Class III

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.

Teva Pharmaceuticals USA
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA and Puerto Rico
Affected count
6,800 cartons
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2017

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