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Showing 4201–4220 of 14370 results

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Progesterone 50 mg Modified Release Capsule (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Finasteride Plus 1.25mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Progesterone Capsules (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Tadalafil Capsules (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Yohimbine HCL Capsules (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

D-Biotin Capsules (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Tadalafil Capsules (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Minoxidil/Biotin Capsules (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Tadalafil 26 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Lack of Processing Controls (lack of assurance of conformity to specifications).

Class IIModerate

FDAJul 2, 2020Nationwide• MasterPharm LLC

Lidothol Patch (Preferred Pharmaceuticals) – Record Misplacement (2020)

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

Class IIModerate

FDAJul 1, 2020Nationwide• Preferred Pharmaceuticals, Inc.

Jamaican Bissy Powder (Sundial) – Misbranded Herbs (2020)

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Class IIModerate

FDAJun 30, 2020NY• Sundial Herbal Products

Bitter Kola Arogbo (Sundial) - Misbranded Drugs (2020)

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Class IIModerate

FDAJun 30, 2020NY• Sundial Herbal Products

Jack in the Herbs (Sundial) - Misbranded Drugs (2020)

Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.

Class IIModerate

FDAJun 30, 2020NY• Sundial Herbal Products

Cetrotide Injection (EMD Serono) – Missing Vial Stopper (2020)

Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.

Class IIModerate

FDAJun 29, 2020Nationwide• EMD Serono, Inc.

Carbamazepine Tablets (RemedyRepack) – Dissolution Specification Failure (2020)

FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

Class IIModerate

FDAJun 29, 2020MN• RemedyRepack Inc.

Calcium Citrate Plus (Vitamin Shoppe) – Sub-Potent Vitamin D (2020)

Sample analysis revealed product is sub-potent for Vitamin D

FDAJun 29, 2020Nationwide• Vitamin Shoppe

Chlorhexidine Gluconate (Medichem) – Microbial Contamination (2020)

Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

FDAJun 24, 2020Nationwide• Medichem S.A.

Tecfidera 240mg Capsules (Biogen) – Manufacturing deviation (2020)

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

FDAJun 23, 2020IN, KY, MS +1 more• Biogen MA Inc.

Nystatin Oral Suspension (VistaPharm) – Impurity Specification Failure (2020)

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

FDAJun 23, 2020Nationwide• VistaPharm, Inc.

Nystatin Oral Suspension (VistaPharm) – Impurity peak excess (2020)

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

FDAJun 23, 2020Nationwide• VistaPharm, Inc.

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