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
- February 17, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0511-2017
- FDA classification
- Class III
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Nationwide in the United States and Puerto Rico
Why it was recalled
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
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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