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Showing 5001–5020 of 14370 results

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Methylergonovine Maleate Tablets (Amneal) – Foreign Tablet Detected (2019)

Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

FDAJul 18, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Sodium Chloride Injection (Baxter) – Sterility Risk (2019)

Lack of Assurance of Sterility: Bags have potential to leak.

Class IIModerate

FDAJul 18, 2019Nationwide• Baxter Healthcare Corporation

Neomycin-Polymyxin-Dexamethasone (Preferred Pharmaceuticals) – Quality Control (2019)

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Class IIModerate

FDAJul 18, 2019CA, FL• Preferred Pharmaceuticals, Inc

Keppra Tablets (Ucb) – Dissolution Failure (2019)

Failed Dissolution Specifications.

Class IIModerate

FDAJul 18, 2019TN• Ucb, Inc

Timolol-Dorzolamide-Latanoprost Drops (ImprimisRx) – Subpotent Drug (2019)

Subpotent Drug

Class IIModerate

FDAJul 17, 2019Nationwide• ImprimisRx NJ

Tamsulosin Hydrochloride Capsules (Macleods) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 17, 2019Nationwide• Macleods Pharma Usa Inc

Timolol-Latanoprost Drops (ImprimisRx) – Subpotent Drug (2019)

Subpotent Drug

Class IIModerate

FDAJul 17, 2019Nationwide• ImprimisRx NJ

Lisinopril-Hydrochlorothiazide Tablets (Lupin) – Tablet Contamination (2019)

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

Class IIModerate

FDAJul 17, 2019Nationwide• Lupin Pharmaceuticals Inc.

Nystatin-Triamcinolone Cream (Lupin) – Uniformity Failure (2019)

Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.

FDAJul 17, 2019Nationwide• Lupin Pharmaceuticals Inc.

Temozolomide Capsules 250mg (Deva Holding) – Cross-Contamination Risk (2019)

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Class IIModerate

FDAJul 16, 2019Nationwide• Deva Holding AS - Cerkezkoy Subesi

Temozolomide Capsules 100mg (Deva Holding) – Cross-Contamination Risk (2019)

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Class IIModerate

FDAJul 16, 2019Nationwide• Deva Holding AS - Cerkezkoy Subesi

Temozolomide Capsules 20mg (Deva Holding) – Cross-Contamination Risk (2019)

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Class IIModerate

FDAJul 16, 2019Nationwide• Deva Holding AS - Cerkezkoy Subesi

Temozolomide Capsules 140mg (Deva Holding) – Cross-Contamination Risk (2019)

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Class IIModerate

FDAJul 16, 2019Nationwide• Deva Holding AS - Cerkezkoy Subesi

Temozolomide Capsules 5mg (Deva Holding) – Cross-Contamination Risk (2019)

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Class IIModerate

FDAJul 16, 2019Nationwide• Deva Holding AS - Cerkezkoy Subesi

Temozolomide Capsules 180mg (Deva Holding) – Cross-Contamination Risk (2019)

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Class IIModerate

FDAJul 16, 2019Nationwide• Deva Holding AS - Cerkezkoy Subesi

Clobazam Oral Suspension (Bionpharma) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

Class IIModerate

FDAJul 16, 2019Nationwide• Bionpharma Inc.

Pain Stopper 500mg Capsules (Herbal Doctor Remedies) – Manufacturing Quality Deviation (2019)

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

Class IIModerate

FDAJul 12, 2019Nationwide• Herbal Doctor Remedies

Hair Back Capsules (Herbal Doctor) - Manufacturing Violations (2019)

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

Class IIModerate

FDAJul 12, 2019Nationwide• Herbal Doctor Remedies

Migraine Off Capsules (Herbal Doctor Remedies) – Manufacturing Quality Deviation (2019)

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

Class IIModerate

FDAJul 12, 2019Nationwide• Herbal Doctor Remedies

Herpes-G Capsules (Herbal Doctor) – Manufacturing Deviation (2019)

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

Class IIModerate

FDAJul 12, 2019Nationwide• Herbal Doctor Remedies

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