Class III · Low risk
Risedronate Sodium Tablets
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Risedronate Sodium Delayed-release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Affected NDCs
0093-5509-19
0093-5509-44
Compare with the code on your package — it is the most precise check available.
Drug: Risedronate
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0093-5509-19
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0431-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Risedronate recalls
See all
Class III · Low risk
Risedronate Sodium Delayed-release Tablets
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Other recalls by Teva Pharmaceuticals USA
All 2016 recalls
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traZODone Hydrochloride Tablets
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Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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