Caraco Pharmaceutical Laboratories
Overview
Caraco Pharmaceutical Laboratories is a pharmaceutical company headquartered in Detroit, United States, founded in 1984, with 201-500 employees.
API / Drug Master Files
Caraco Pharmaceutical Laboratories holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- FACILITY IN DETROIT, MICHIGAN.Inactive1992-10-24
FDA compliance signals
12 FDA enforcement records linked to this company.
- recall — Class II2014-08-13
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
- recall — Class II2014-08-13
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
- recall — Class II2014-07-09
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
- recall — Class II2014-07-02
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
- recall — Class III2014-05-07
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
- recall — Class II2014-05-07
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
- recall — Class III2014-05-07
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
- recall — Class II2014-05-07
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
- recall — Class II2014-03-05
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
- recall — Class II2014-02-19
Failed Tablet Specifications: Broken Tablets Present.
- recall — Class II2012-12-12
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.
- recall — Class II2012-10-10
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
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