- Nearly a million bottles of Corlanor and Sensipar—two medications made by the company Amgen—have been recalled, according to the FDA.
- These are Class II recalls, meaning the affected bottles of medication may cause temporary and reversible effects.
- If your medication is affected, ask your healthcare provider how to proceed.
The Food and Drug Administration (FDA) has issued a report warning that nearly a million bottles of medication—at least 944,142, to be exact—have been recalled nationwide. The affected drugs include Corlanor, a medication prescribed to treat chronic heart failure, and Sensipar, a drug used to treat chronic kidney disease, among other conditions—two brand-name prescription medications made by the biotech company Amgen.
According to the FDA report, the Corlanor bottles were recalled due to the “presence of a foreign substance,” while the Sensipar bottles were recalled due to deviations from the FDA’s Current Good Manufacturing Practice (CGMP) regulations, which are used to ensure quality and safety. Both the Corlanor and Sensipar recalls are classified as Class II, which the FDA defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Below, how to tell if your medication is affected, and what to do with recalled pills.
How to identify recalled medication
Check your bottles for these lot numbers and NDC codes:
Corlanor (ivabradine)
5-mg tablets, packaged in 14-count bottles
- NDC: 55513-800-99
- Lot numbers: 1138901, 1149846
5-mg tablets, packaged in 60-count bottles
- NDC: 55513-800-60
- Lot numbers: 1138201, 1138202, 1138900, 1141143, 1140280, 1140281, 1142063, 1142062, 1142942, 1142943, 1144081, 1144104, 1146373, 1146374, 1147491, 1147492, 1149843, 1151113, 1151890, 1153401, 1151114, 1151115, 1152412, 1153399, 1153400, 1155834, 1155835, 1155836, 1158480, 1158481, 1158482, 1160354, 1160355, 1161593, 1161594, 1161595, 1164097, 1164098, 1164099, 1165078, 1165079, 1165080, 1168005, 1168006, 1168007, 1169288, 1169289, 1172885
7.5-mg tablets, packaged in 60-count bottles
- NDC: 55513-810-60
- Lot numbers: 1138203, 1142065, 1145151, 1145152, 1145153, 1148908, 1148909, 1162845, 1162846, 1166471, 1166472, 1166473, 1170615
Sensipar (cinacalcet)
30mg tablets, 30-count bottles
- NDC: 55513-073-30
- Lot number: 1156858
60mg, 30-count bottles
- NDC: 55513-074-30
- Lot number: 1157055
90mg, 30-count bottles
- NDC: 55513-075-30
- Lot number: 1157056
What to do with affected bottles
If your medication is affected, consult with your pharmacist or physician on the best course of action. Do not stop taking your medication unless a healthcare provider explicitly advises you to do so.
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