Search Product Recalls

FDAJul 26, 2016MS• Pharmacy Plus, Inc. dba Vital Care Compounder

Moxifloxacin/Dexamethazone 0.5%/0.1% (Vital Care Compounder) – Sterility Risk (2016)

Lack of Assurance of Sterility

FDAJul 26, 2016MS• Pharmacy Plus, Inc. dba Vital Care Compounder

DMSO with Lidocaine (Vital Care) – Sterility Concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 26, 2016MS• Pharmacy Plus, Inc. dba Vital Care Compounder

Cetylev Effervescent Tablets (Arbor Pharmaceuticals) – Defective Container (2016)

Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.

Class IHigh

FDAJul 21, 2016CA, FL, GA +11 more• Arbor Pharmaceuticals Inc.

Sermorelin Injection (Talon) – Sterility Concern (2016)

Lack of Assurance of Sterility

FDAJul 19, 2016Nationwide• Talon Compounding Pharmacy

Human Chorionic Gonadotropin Injection (Talon) – Sterility Concern (2016)

Lack of Assurance of Sterility

FDAJul 19, 2016Nationwide• Talon Compounding Pharmacy

Venlafaxine HCL ER 150mg (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications: out of specification dissolution results in retained samples

FDAJul 19, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Venlafaxine HCL ER Capsule (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications: out of specification dissolution results in retained samples

FDAJul 19, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Bactroban Nasal (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Bactroban Cream (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

Bactroban Ointment (GlaxoSmithKline) – Penicillin Contamination (2016)

Penicillin Cross Contamination

FDAJul 15, 2016Nationwide• Teva North America

Children's Qnasl (Teva) – Content Uniformity Issue (2016)

Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Class IIILow

Trokendi XR Capsules (Supernus) – Superpotent Drug Issue (2016)

Superpotent Drug: Failure of assay specifications in the capsule.

FDAJul 12, 2016Nationwide• Supernus Pharmaceuticals, Inc.

Dextroamphetamine Sulfate Capsules (Actavis) – Failed Dissolution (2016)

Failed Dissolution Specifications

FDAJul 11, 2016Nationwide• Actavis Inc

Acyclovir Tablets (Safecor) – CGMP Deviation (2016)

CGMP Deviations

Doxycycline Tablets (Safecor) – CGMP Deviation (2016)

CGMP Deviations

Atorvastatin Calcium Tablets (Safecor) – CGMP Deviation (2016)

CGMP Deviations

Calcium Carbonate/Vitamin D3 Tablets (Safecor) – CGMP Deviation (2016)

CGMP Deviations

Metronidazole Tablets (Safecor) – CGMP Deviation (2016)

CGMP Deviations