CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Caraco Pharmaceutical Laboratories
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
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 I - Dangerous
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Failed Tablet Specifications: Broken Tablets Present.
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.
Crystallization: Presence of crystals of Nimodipine within the capsule solution.