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Showing 4581–4600 of 14370 results

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Ranitidine 150 mg Tablets (Glenmark) - NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDADec 17, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Panther Platinum 30000 Capsules (Motto International) - Undeclared Tadalafil (2019)

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

FDADec 17, 2019TX• Motto International Corp

Stallion Platinum 30000 Capsules (Motto International) - Undeclared Tadalafil (2019)

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Class IHigh

FDADec 17, 2019TX• Motto International Corp

Ranitidine 300 mg Tablets (Glenmark) - NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDADec 17, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

NORepinephrine Bitartrate Injection (Pharmedium) – Subpotent Drug (2019)

Subpotent Drug

FDADec 16, 2019Nationwide• Pharmedium Services, LLC

NORepinephrine Bitartrate Injection (Pharmedium) – Subpotent Drug (2019)

Subpotent Drug

FDADec 16, 2019Nationwide• Pharmedium Services, LLC

NORepinephrine Bitartrate Injection (Pharmedium) – Subpotent Drug (2019)

Subpotent Drug

FDADec 16, 2019Nationwide• Pharmedium Services, LLC

Hydrocortisone Acetic Acid Otic Solution (Akorn) – Low Assay Results (2019)

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Class IIModerate

FDADec 16, 2019Nationwide• Akorn Inc

Memantine Hydrochloride Capsules (Harvard Drug) – Failed Dissolution (2019)

Failed Dissolution Specifications: High out of specification result observed at stability studies.

FDADec 13, 2019Nationwide• The Harvard Drug Group

Bimatoprost Ophthalmic Solution (Lupin) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

FDADec 13, 2019Nationwide• Lupin Pharmaceuticals Inc.

Estriol Micronized (Spectrum Lab) – Subpotent Drug (2019)

Subpotent Drug: Supplier indicated assay results did not meet specifications.

Class IIModerate

FDADec 11, 2019Nationwide• Spectrum Laboratory Products

Memantine Hydrochloride Capsules (Lupin) – Failed Dissolution (2019)

Failed Dissolution Specifications: High out of specification result observed at stability studies.

FDADec 10, 2019Nationwide• Lupin Pharmaceuticals Inc.

Estriol Micronized (Enovachem) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class IIModerate

FDADec 9, 2019CA• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Estriol Micronized (Enovachem) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class IIModerate

FDADec 9, 2019CA• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Estriol Micronized (Enovachem) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Class IIModerate

FDADec 9, 2019CA• Asclemed USA Inc. dba Enovachem Pharmaceuticals

Levetiracetam Oral Solution (Lannett) – Microbial Contamination (2019)

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

FDADec 6, 2019Nationwide• Lannett Company, Inc.

Raloxifene Tablets (American Health) – Failed Dissolution (2019)

Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

Class IIModerate

FDADec 4, 2019Nationwide• American Health Packaging

Ranitidine Tablets (Preferred Pharma) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDADec 2, 2019CA, FL• Preferred Pharmaceuticals, Inc

Amantadine Tablets (Jubilant Cadista) – Foreign Substance (2019)

Presence of Foreign Substance: Presence of a foreign object in a single tablet.

Class IIModerate

FDADec 2, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Moxifloxacin Ophthalmic Solution (AuroMedics) – Discoloration (2019)

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

FDADec 2, 2019Nationwide• AuroMedics Pharma LLC

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