Caraco Pharmaceutical Laboratories recalls

Caraco Pharmaceutical Laboratories appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2014-08-13.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only,…
  FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories
  Reason: CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
• Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only,…
  FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories
  Reason: CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
• Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles
  FDA Drug · Class II · 2014-07-09 · Caraco Pharmaceutical Laboratories
  Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
• Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmac…
  FDA Drug · Class II · 2014-07-02 · Caraco Pharmaceutical Laboratories
  Reason: Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
• Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5)
  FDA Drug · Class II · 2014-05-07 · Caraco Pharmaceutical Laboratories
  Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
• Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
  FDA Drug · Class III · 2014-05-07 · Caraco Pharmaceutical Laboratories
  Reason: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
• Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed…
  FDA Drug · Class III · 2014-05-07 · Caraco Pharmaceutical Laboratories
  Reason: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
• Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2)
  FDA Drug · Class II · 2014-05-07 · Caraco Pharmaceutical Laboratories
  Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
• Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc
  FDA Drug · Class II · 2014-03-05 · Caraco Pharmaceutical Laboratories
  Reason: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
• Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only
  FDA Drug · Class II · 2014-02-19 · Caraco Pharmaceutical Laboratories
  Reason: Failed Tablet Specifications: Broken Tablets Present.
• traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, I…
  FDA Drug · Class II · 2012-12-12 · Caraco Pharmaceutical Laboratories
  Reason: 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.
• Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-13…
  FDA Drug · Class II · 2012-10-10 · Caraco Pharmaceutical Laboratories
  Reason: Crystallization: Presence of crystals of Nimodipine within the capsule solution.