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Showing 8161–8180 of 15081 results

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Lisinopril 5mg Tablets (Accord) – Missing Break Line (2016)

Failed tablet/capsule specification: missing break line on the 5mg tablet.

Class IIModerate

FDADec 20, 2016Nationwide• Accord Healthcare, Inc.

Temozolomide 100mg Capsules (Mylan) – Capsule Integrity (2016)

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

Class IIModerate

FDADec 20, 2016Nationwide• Mylan LLC.

Bupropion Extended-Release 150mg (Sun) – Dissolution Failure (2016)

Failed Dissolution Specifications; 18 month stability time point

Class IIILow

FDADec 20, 2016Nationwide• Sun Pharmaceutical Industries, Inc.

Aripiprazole 2mg Tablets (Apotex) – Superpotency Risk (2016)

Superpotent Drug: Product may not meet specifications throughout shelf life.

FDADec 19, 2016Nationwide• Apotex Inc.

Pantoprazole Sodium Injection (Aurobindo) – Discoloration Issue (2016)

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

FDADec 16, 2016Nationwide• Aurobindo Pharma USA Inc

Midazolam Injection (Fresenius) – Impurity Specification (2016)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 16, 2016Nationwide• Fresenius Kabi USA, LLC

Kyprolis Injection (Amgen) – Vial Integrity Concern (2016)

Lack of Assurance of Sterility: Potential cracks in glass vials

Class IIModerate

FDADec 15, 2016Nationwide• Amgen, Inc.

Phenylephrine Tropicamide Eye Drops (Meta) – Sterility Issue (2016)

Lack of Sterility Assurance

Class IIModerate

FDADec 15, 2016IN• Meta Pharmacy Services

Azelastine Nasal Spray (Roxane) – Droplet Size Problem (2016)

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

FDADec 14, 2016Nationwide• Roxane Laboratories, Inc.

Torsemide 20mg Tablets (Apotex) – CGMP Deviation (2016)

CGMP Deviations

Class IIModerate

FDADec 14, 2016Nationwide• Apotex Corp.

Torsemide 5mg Tablets (Apotex) – CGMP Deviation (2016)

CGMP Deviations

Class IIModerate

FDADec 14, 2016Nationwide• Apotex Corp.

Donepezil Hydrochloride Tablets (Sandoz Inc) – Subpotent Drug (2016)

Subpotent Drug: out of specification results for assay test.

FDADec 13, 2016Nationwide• Sandoz Inc

Nano PNC Water (Pacific Medical Solutions) – Non-Sterile Rx Solution (2016)

Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.

FDADec 13, 2016Nationwide• Pacific Medical Solutions

Virt-Select Prenatal Softgels (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

Rabeprazole Sodium Tablets (Amneal) – Failed Dissolution (2016)

Failed Dissolution Specifications

Class IIModerate

FDADec 12, 2016Nationwide• Amneal Pharmaceuticals LLC

Vitamin D-3 Supplement (Source Naturals) – Concentration Deviation (2016)

Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.

Class IIModerate

FDADec 12, 2016Nationwide• Threshold Enterprises Ltd

Extra-Virt Plus DHA Softgel (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

VirtPrex Prenatal Tablets (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

Virt-Advance Prenatal Softgels (Virtus Pharmaceuticals) – API Import Alert (2016)

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

FDADec 12, 2016Nationwide• VIRTUS PHARMACEUTICALS OPCO II L

SLIMFIT X Capsules (Jersey Shore Supplements) – Undeclared Ingredients (2016)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.

FDADec 9, 2016MD, NJ• Jersey Shore Supplements, LLC

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