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Showing 8141–8160 of 15081 results

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Diphenhydramine HCl Softgel (InnovaGel) – Subpotent (2017)

Subpotent

Class IIILow

FDAJan 5, 2017NY• InnovaGel

Fluconazole Tablets 100mg (Harvard) – Failed Dissolution (2017)

Failed Dissolution Specifications

Class IIModerate

FDAJan 5, 2017Nationwide• The Harvard Drug Group

Dye Free Allergy Softgel (InnovaGel) – Subpotent (2017)

Subpotent

Class IIILow

FDAJan 5, 2017NY• InnovaGel

Donepezil HCl Tablets (Mckesson) – Subpotent (2017)

Supotent: Out of Specification result for assay test during routine stability testing.

Class IIILow

FDAJan 4, 2017CO, LA, OH• Mckesson Packaging Services

Finasteride Tablets (Hetero) – Thickness Specification (2016)

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Class IIILow

FDADec 29, 2016NJ• Hetero Drugs Ltd. - Unit 1

Flucanozole Tablets 150mg (Dr. Reddy's) – Failed Dissolution (2016)

Failed Dissolution Specifications; 18 month stability time point

Class IIModerate

FDADec 28, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

Clindamycin Benzoyl Peroxide Gel (Perrigo) – Mold Contamination (2016)

Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

Class IIModerate

FDADec 28, 2016Nationwide• L. Perrigo Company

Flucanozole Tablets 200mg (Dr. Reddy's) – Failed Dissolution (2016)

Failed Dissolution Specifications; 18 month stability time point

Class IIModerate

FDADec 28, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

Flucanozole Tablets 100mg (Dr. Reddy's) – Failed Dissolution (2016)

Failed Dissolution Specifications; 18 month stability time point

Class IIModerate

FDADec 28, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

Flucanozole Tablets 50mg (Dr. Reddy's) – Failed Dissolution (2016)

Failed Dissolution Specifications; 18 month stability time point

Class IIModerate

FDADec 28, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

Aripiprazole Tablets (Harvard) – Superpotent Drug (2016)

Superpotent Drug; out of specification results for assay (manufacturer)

Class IIILow

FDADec 27, 2016Nationwide• The Harvard Drug Group

Nadolol Tablets (Sandoz) – Dissolution Specification Failure (2016)

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

Class IIModerate

FDADec 22, 2016MS, OH• Sandoz Incorporated

Temazepam Capsules (Qualitest) – Failed Stability (2016)

Failed Stability Specifications

Class IIILow

FDADec 22, 2016Nationwide• Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Furosemide Tablets (Roxane) – Thick Tablet Issue (2016)

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

Class IIModerate

FDADec 22, 2016Nationwide• Roxane Laboratories, Inc.

Venlafaxine Capsules (Aurobindo) – Capsule Defect (2016)

Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.

Class IIModerate

FDADec 22, 2016Nationwide• Aurobindo Pharma USA Inc

Amoxicillin Suspension (Teva) – Subpotency Concern (2016)

Subpotency: due to a low, out of specification test result for assay during stability testing.

Class IIModerate

FDADec 21, 2016Nationwide• Teva Pharmaceuticals USA

Temozolomide 140mg 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.

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.

Temozolomide 250mg 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.

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.

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