FDA-Drug2017-03-15Class 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: low out of specification dissolution results found during stability testing.
Sold states
Nationwide in the United States and Puerto Rico
Affected count
25,916 cartons
Manufactured in
1090 Horsham Rd, N/A, 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-0511-2017Don't want to check this manually?
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