Caraco Pharmaceutical Laboratories, Ltd. Recalls

All product recalls associated with Caraco Pharmaceutical Laboratories, Ltd..

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Recall Summary

Total Recalls

12

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2014

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–12 of 12 recalls

Cephalexin Capsules 500mg (Caraco) – Manufacturing Deviation (2014)

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 IIModerate

FDAJun 26, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Cephalexin Capsules 250mg (Caraco) – Manufacturing Deviation (2014)

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 IIModerate

FDAJun 26, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Venlafaxine (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Class IIModerate

FDAJun 12, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Cetirizine Chewables (Caraco) – impurity concern (2014)

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Class IIILow

FDAApr 9, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Gemcitabine Injection (Caraco) – sterility concern (2014)

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 IIModerate

FDAApr 9, 2014OH• Caraco Pharmaceutical Laboratories, Ltd.

Children's Cetirizine Chewables (Caraco) – impurity issue (2014)

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Class IIILow

FDAApr 9, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Venlafaxine ER Tablets 37.5mg (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Class IIModerate

FDAMar 20, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Venlafaxine ER Tablets 150mg (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Class IIModerate

FDAMar 20, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Oxcarbazepine Tablets (Caraco) – Broken Tablets (2014)

Failed Tablet Specifications: Broken Tablets Present.

Class IIModerate

FDAJan 29, 2014Nationwide• Caraco Pharmaceutical Laboratories Ltd.

Metformin HCl Extended-Release (Caraco) – Foreign Tablet Contamination (2014)

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Class IIModerate

FDAJan 28, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Tramadol Tablets (Caraco) – foreign tablet contamination (2012)

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.

Class IIModerate

FDANov 5, 2012Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Nimodipine Capsules (Caraco) – Crystallization issue (2012)

Crystallization: Presence of crystals of Nimodipine within the capsule solution.

Class IIModerate

FDAAug 21, 2012MI• Caraco Pharmaceutical Laboratories Ltd.

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Caraco Pharmaceutical Laboratories, Ltd. Recalls

Recall Summary

Cephalexin Capsules 500mg (Caraco) – Manufacturing Deviation (2014)

Cephalexin Capsules 250mg (Caraco) – Manufacturing Deviation (2014)

Venlafaxine (Caraco) – Dissolution Failure (2014)

Cetirizine Chewables (Caraco) – impurity concern (2014)

Gemcitabine Injection (Caraco) – sterility concern (2014)

Children's Cetirizine Chewables (Caraco) – impurity issue (2014)

Venlafaxine ER Tablets 37.5mg (Caraco) – Dissolution Failure (2014)

Venlafaxine ER Tablets 150mg (Caraco) – Dissolution Failure (2014)

Oxcarbazepine Tablets (Caraco) – Broken Tablets (2014)

Metformin HCl Extended-Release (Caraco) – Foreign Tablet Contamination (2014)

Tramadol Tablets (Caraco) – foreign tablet contamination (2012)

Nimodipine Capsules (Caraco) – Crystallization issue (2012)