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Showing 1441–1460 of 2326 results

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Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

Daytrana 10mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 30mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 20mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

NaturalCare Allergy Drops (Nutraceutical) – raw material discoloration (2023)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Class IIModerate

FDAFeb 23, 2023Nationwide• Nutraceutical Corporation

bioAllers Mold Drops (Nutraceutical) – Material Discoloration (2023)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Class IIModerate

FDAFeb 23, 2023Nationwide• Nutraceutical Corporation

Cold & Sinus Nasal Spray (Nutraceutical) – Material Discoloration (2023)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Class IIModerate

FDAFeb 23, 2023Nationwide• Nutraceutical Corporation

bioAllers Nasal Spray (Nutraceutical) – Material Discoloration (2023)

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Class IIModerate

FDAFeb 23, 2023Nationwide• Nutraceutical Corporation

MSM Nasal Spray (Pharmedica USA) – CGMP Deviation (2023)

CGMP Deviations

Class IIModerate

FDAFeb 14, 2023Nationwide• Pharmedica USA, LLC

Fentanyl and Ropivacaine Solution (Apollo Care) - Sterility Concern (2023)

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Class IIModerate

FDAFeb 8, 2023MO• Apollo Care

Tacrolimus Capsules (Dr. Reddy's) - Incorrect Capsule Mix (2023)

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Class IIModerate

FDAFeb 8, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

Delsam Artificial Tears (Global Pharma) – CGMP Deviation (2023)

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Class IIModerate

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Artificial Tears Eye Drops (Global Pharma) – CGMP Deviation (2023)

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Class IIModerate

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Class IIModerate

FDAJan 17, 2023Nationwide• Fisher Scientific Co., LLC

Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Class IIModerate

FDAJan 17, 2023Nationwide• Fisher Scientific Co., LLC

Techni-Care Chloroxylenold (Consolidated) - CGMP Violation (2023)

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Class IIModerate

FDAJan 10, 2023Nationwide• Consolidated Chemical, Inc

Humatrix Microclysmic Gel (Consolidated) - CGMP Violation (2023)

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Class IIModerate

FDAJan 10, 2023Nationwide• Consolidated Chemical, Inc

Acyclovir Sodium Injection (Eugia US) – particulate matter (2022)

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

Class IIModerate

FDADec 28, 2022Nationwide• Eugia US LLC

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