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Showing 4541–4560 of 14370 results

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Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Class IIModerate

FDAJan 7, 2020Nationwide• Mylan Pharmaceuticals Inc.

Ranitidine Capsules (Appco Pharma) – NDMA Impurity (2020)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDAJan 7, 2020Nationwide• Appco Pharma LLC

Dutasteride Capsules (AVKARE) – High Impurities (2020)

Failed Impurities/Degradation Specifications: High out of specification results for related compounds.

Class IIModerate

FDAJan 7, 2020Nationwide• AVKARE Inc.

Ranitidine Capsules (Appco Pharma) – NDMA Impurity (2020)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDAJan 7, 2020Nationwide• Appco Pharma LLC

Ranitidine Tablets (Preferred Pharmaceuticals) – NDMA Contamination (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAJan 7, 2020AL, AZ, CA +4 more• Preferred Pharmaceuticals, Inc

Ranitidine Tablets (Preferred Pharmaceuticals) – NDMA Contamination (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAJan 7, 2020AL, AZ, CA +4 more• Preferred Pharmaceuticals, Inc

Ketorolac Trom Injection (RemedyRepack) – Particulate Matter (2019)

Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

FDADec 27, 2019IN, LA, OK• RemedyRepack Inc.

Blisovi Fe 1.5/30 (Lupin) – Tablet Crumbling (2019)

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Class IIModerate

FDADec 26, 2019Nationwide• Lupin Pharmaceuticals Inc.

Sumatriptan Tablets 100mg (Sun Pharma) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Class IIModerate

FDADec 26, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Sumatriptan Tablets 50mg (Sun Pharma) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Class IIModerate

FDADec 26, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Proparacaine Ophthalmic Solution (Akorn) – Chemical Contamination (2019)

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

FDADec 26, 2019Nationwide• Akorn, Inc.

Ranitidine Tablets 150mg (Denton Pharma) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDADec 20, 2019Nationwide• Denton Pharma, Inc.

Ranitidine 300mg Tablets (Denton Pharma) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDADec 20, 2019Nationwide• Denton Pharma, Inc.

Lamotrigine 100mg Tablets (Taro Pharmaceuticals) – Cross Contamination (2019)

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

FDADec 20, 2019Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Sildenafil 80 mg Capsules (Medical Park Pharmacy) - Expired Components (2019)

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Class IIModerate

FDADec 18, 2019TX• MPRX, Inc. dba Medical Park Pharmacy

T3/T4 SR 9/38 mcg Capsule (Medical Park Pharmacy) - Expired Components (2019)

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Class IIModerate

FDADec 18, 2019TX• MPRX, Inc. dba Medical Park Pharmacy

Finasteride/Biotin Supplement (Medical Park Pharmacy) – expired components (2019)

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Class IIModerate

FDADec 18, 2019TX• MPRX, Inc. dba Medical Park Pharmacy

Magic Bullet Supplement (Medical Park Pharmacy) – expired components (2019)

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Class IIModerate

FDADec 18, 2019TX• MPRX, Inc. dba Medical Park Pharmacy

Sildenafil 200MG Troche (Medical Park Pharmacy) – expired components (2019)

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Class IIModerate

FDADec 18, 2019TX• MPRX, Inc. dba Medical Park Pharmacy

DHEA/Pregnenol One Capsule (Medical Park Pharmacy) – expired components (2019)

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Class IIModerate

FDADec 18, 2019TX• MPRX, Inc. dba Medical Park Pharmacy

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