Teva Pharmaceuticals USA recalls Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4…
- Recall date
- December 1, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0431-2017
- FDA classification
- Class III
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
Failed Dissolution Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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