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Showing 1621–1640 of 2521 results

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Metoprolol Succinate Tablets (Wockhardt) – failed dissolution (2014)

Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

FDAApr 17, 2014Nationwide• Wockhardt Usa Inc.

Triacting Cold & Cough (P&L) – solution precipitation (2014)

Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

FDAApr 15, 2014Nationwide• P&L Developments, LLC

Tussin DM (Aaron Industries) – ingredient precipitation (2014)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.

Class IIILow

FDAApr 11, 2014Nationwide• Aaron Industries Inc

Cetirizine Chewables (Caraco) – impurity concern (2014)

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

FDAApr 9, 2014Nationwide• 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

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

Allergy Support (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Back Health Plus (Good Herbs) – Poor Manufacturing (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Chinese Salvia (Good Herbs) – Manufacturing Quality Concerns (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Echinacea Angustifolia (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Cramp Bark (Good Herbs) – Poor Manufacturing (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Environmental Formula (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Cat's Claw (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Flower Essence Elm (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Burdock (Good Herbs) – Manufacturing Quality Concerns (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Endometrial Support (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Astragalus (Good Herbs) – Poor Manufacturing (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Chaparral (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Clove (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Flower Essence Clematis (Good Herbs) – Manufacturing Quality Issue (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Cramp Bark Formula (Good Herbs) – Poor Manufacturing (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMar 25, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

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