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Showing 1861–1880 of 3363 results

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Quillivant XR 900mg (Pfizer) – Failed Dissolution (2017)

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

FDAMar 7, 2017Nationwide• Pfizer Inc

Adalat CC Tablets 30mg (Alvogen) – Cross Contamination (2017)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

FDAMar 7, 2017Nationwide• Alvogen, Inc

Nifedipine Extended-Release Tablets (Alvogen) – Cross Contamination (2017)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Class IIILow

FDAMar 7, 2017Nationwide• Alvogen, Inc

Adalat CC Tablets 60mg (Alvogen) – Cross Contamination (2017)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

FDAMar 7, 2017Nationwide• Alvogen, Inc

Indian God Lotion Spray (A&H Focal) – Unapproved Ingredient (2017)

Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

FDAMar 7, 2017NJ, NY• A&H Focal Inc.

Nifedipine 90mg Tablets (Alvogen) – Cross Contamination (2017)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

FDAMar 7, 2017Nationwide• Alvogen, Inc

Nifedipine 60mg Tablets (Alvogen) – Cross Contamination (2017)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

FDAMar 7, 2017Nationwide• Alvogen, Inc

Rivastigmine Capsules (Dr. Reddy's) - Cross-Contamination Risk (2017)

Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

FDAMar 6, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Vegetarian Tuna Fish (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Fat-Choy Style Vegetable Soup (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Braised Bean Curd (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Vegetarian Minced Meat (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Kung-Pao Sauce (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Braised Bamboo Shoot Tips (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Braised Bamboo Shoot Tips with Chili (Companion Foods) – Undeclared Wheat (2017)

An FDA inspection at the manufacturing facility found seven products that do not properly declare wheat as a sub-ingredient of soy sauce in the ingredient list. Wheat is listed in the Contains statement.

FDAMar 1, 2017CA, IL, NJ• Companion Foods Corp.

Clindamycin Solution (G & W Laboratories) - Expired Ingredient (2017)

CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.

FDAFeb 28, 2017Nationwide• G & W Laboratories, Inc.

Penicillin V Tablets (Citron Pharma) - Foreign Tablet Mix-up (2017)

Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg

FDAFeb 24, 2017Nationwide• Citron Pharma Llc

Fluocinolone Acetonide Solution (Novel Laboratories) – chemical contamination (2017)

Chemical Contamination

FDAFeb 22, 2017Nationwide• Novel Laboratories, Inc.

Mini Pecan Tarts (Give and Go) – weevil larvae (2017)

Dried weevil larvae may be present in the recalled products.

FDAFeb 21, 2017Nationwide• Give and Go Prepared Foods Corp - Finch

Two-Bite Turtle Brownie Platter (Give and Go) – weevil larvae (2017)

Dried weevil larvae may be present in the recalled products.

FDAFeb 21, 2017Nationwide• Give and Go Prepared Foods Corp - Finch

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