Caraco Pharmaceutical Laboratories recalls
FDA enforcement reports naming Caraco Pharmaceutical Laboratories Ltd. as the recalling firm.
- Recall reports
- 12
- Class I (serious)
- 0
- Most recent report
- Aug 13, 2014
- Aug 13, 2014Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) a…Drug · Caraco Pharmaceutical Laboratories, Ltd.CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.Class II
- Aug 13, 2014Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) a…Drug · Caraco Pharmaceutical Laboratories, Ltd.CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.Class II
- Jul 9, 2014Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Cou…Drug · Caraco Pharmaceutical Laboratories, Ltd.Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.Class II
- Jul 2, 2014Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Si…Drug · Caraco Pharmaceutical Laboratories, Ltd.Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.Class II
- May 7, 2014Venlafaxine Hydrochloride Extended-Release Tablets, 37Drug · Caraco Pharmaceutical Laboratories, Ltd.Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.Class II
- May 7, 2014Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Ma…Drug · Caraco Pharmaceutical Laboratories, Ltd.Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-OxideClass III
- May 7, 2014Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bot…Drug · Caraco Pharmaceutical Laboratories, Ltd.Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.Class II
- May 7, 2014Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by S…Drug · Caraco Pharmaceutical Laboratories, Ltd.Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-OxideClass III
- Mar 5, 2014Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manuf…Drug · Caraco Pharmaceutical Laboratories, Ltd.Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ERClass II
- Feb 19, 2014Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx OnlyDrug · Caraco Pharmaceutical Laboratories Ltd.Failed Tablet Specifications: Broken Tablets Present.Class II
- traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured…
- Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose C…
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