Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count…
Reason Subpotent drug
Cholesterol Medication Recalls
Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.
161 recalls in this category, newest first.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's…
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count…
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count…
Reason Subpotent drug
Class III · Low risk Terminated
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured…
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk Terminated
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured…
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk Terminated
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only…
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class II · Moderate risk Terminated
Simvastatin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Gemfibrozil active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Ezetimibe active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class III · Low risk Terminated
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured…
Reason Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class II · Moderate risk Terminated
Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Reason Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc…
Reason Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of…
Class III · Low risk Terminated
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC…
Reason Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or…
Class III · Low risk Terminated
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC…
Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…
Class III · Low risk Terminated
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC…
Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…
Class III · Low risk Terminated
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC…
Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…
Class II · Moderate risk Terminated
FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.
Reason Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG…
Class II · Moderate risk Terminated
ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212277.
Reason Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID…
Class II · Moderate risk Terminated
ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212177 .
Reason Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM…
Class II · Moderate risk Terminated
ATORVASTATIN CALCIUM, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201777.
Reason Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: COENZYME Q-10…
Class II · Moderate risk Terminated
ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201577.
Reason Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR…
Class II · Moderate risk Terminated
ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00310075590.
Reason Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400…
Class II · Moderate risk Terminated
LOVASTATIN, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185007201.
Reason Labeling: Label Mixup: LOVASTATIN, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: ASPIRIN EC DR, Tablet, 81 mg…
Class II · Moderate risk Terminated
FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115551110.
Reason Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the following drug: FAMCICLOVIR, Tablet, 500 mg, NDC…
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