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Caraco Pharmaceutical Laboratories Recalls
12 recalls on record · October 10, 2012 to August 13, 2014 · Drugs
Recalls by year
12
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 13, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 6275
Hazard: CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
August 13, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 6275
Hazard: CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
July 9, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distribu
Hazard: Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
July 2, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactu
Hazard: Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
May 7, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat
Hazard: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
May 7, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47
Hazard: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
May 7, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41
Hazard: Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
May 7, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 416
Hazard: Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
March 5, 2014DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical In
Hazard: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
February 19, 2014DrugsFDA
Caraco Pharmaceutical Laboratories Ltd. recalls Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1
Hazard: Failed Tablet Specifications: Broken Tablets Present.
December 12, 2012DrugsFDA
Caraco Pharmaceutical Laboratories, Ltd. recalls traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industrie
Hazard: Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
October 10, 2012DrugsFDA
Caraco Pharmaceutical Laboratories Ltd. recalls Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per ca
Hazard: Crystallization: Presence of crystals of Nimodipine within the capsule solution.