Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured…
Reason Failed Dissolution Specifications
Is Atorvastatin recalled?
67 FDA recalls mention Atorvastatin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Atorvastatin.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c)…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c)…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05)…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009…
Reason Failed dissolution specifications: lower than specifications
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc…
Reason Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium…
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC…
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC…
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Terminated
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx…
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited…
Reason Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class III · Low risk Terminated
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500…
Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class III · Low risk Terminated
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05…
Reason Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited…
Reason Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Class II · Moderate risk Terminated
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs…
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing…
Class II · Moderate risk Terminated
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs…
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing…
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009…
Reason Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing…
Class III · Low risk Terminated
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L…
Reason Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409…
Reason Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month…
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