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Showing 4301–4320 of 14370 results

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Nizatidine Oral Solution (Amneal) – NDMA Contamination Risk (2020)

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Class IIModerate

FDAApr 15, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Advanced Joint Relief Capsules (Absorb Health) – allergen warning (2020)

The firm was notified by the FDA that they failed to included a shellfish allergen on their ingredient panel.

Class IIModerate

FDAApr 15, 2020AZ, CA, FL +14 more• Absorb Health LLC

Acetaminophen Codeine Tablet (Pharma Pac) – Quality Deviation (2020)

cGMP Deviations

Class IIModerate

FDAApr 15, 2020AZ, CA, IN• H J Harkins Company Inc dba Pharma Pac

Estradiol (B & B Pharmaceuticals) – Foreign Material Risk (2020)

cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.

Class IIModerate

FDAApr 14, 2020Nationwide• B & B Pharmaceuticals, Inc.

Finasteride Plus Capsule (MasterPharm) – Cross Contamination (2020)

Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.

FDAApr 14, 2020Nationwide• MasterPharm LLC

Estradiol Capsule (Medicine Shoppe) – Processing Control (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Levothyroxin/Liothyronine SR Capsules (The Medicine Shoppe) – Processing Control Issue (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Bi-Est/Progesterone/Testosterone Capsules (The Medicine Shoppe) – Processing Control Issue (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Progesterone Capsules (The Medicine Shoppe) – processing control (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Bi-Est/Progesterone Capsules (The Medicine Shoppe) – processing control (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Betahistine Capsule (Medicine Shoppe) – Processing Control (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Naltrexone Capsules (The Medicine Shoppe) – processing control (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Biotin 1000mcg Supplement (Golden Nutrition) – Low Potency (2020)

FDA sample analysis of Biotin 1000mg Lot #1345 showed the product Biotin content to be 0.8% of label claim.

FDAApr 6, 2020Nationwide• GOLDEN NUTRITION INC

Diethylstilbestrol Capsules (The Medicine Shoppe) – Processing Control Issue (2020)

Lack of Processing Control

Class IIModerate

FDAApr 6, 2020FL• The Medicine Shoppe Pharmacy

Losartan Potassium Tablets (Golden State) – CGMP Impurity Detection (2020)

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

Class IIModerate

FDAApr 3, 2020Nationwide• Golden State Medical Supply Inc.

Lisinopril Tablets (Lupin) – Tablet Mix-up Risk (2020)

Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.

Class IIModerate

FDAApr 1, 2020Nationwide• Lupin Pharmaceuticals Inc.

Daytrana 10mg Patch (Noven) – Delivery System Defect (2020)

Defective Delivery System: Out of specification for mechanical peel and shear.

Class IIModerate

FDAMar 31, 2020Nationwide• Noven Therapeutics, LLC

Daytrana 20mg Patch (Noven) – Delivery System Defect (2020)

Defective Delivery System: Out of specification for mechanical peel and shear.

Class IIModerate

FDAMar 31, 2020Nationwide• Noven Therapeutics, LLC

Daytrana 30mg Patch (Noven) – Delivery System Defect (2020)

Defective Delivery System: Out of specification for mechanical peel and shear.

Class IIModerate

FDAMar 31, 2020Nationwide• Noven Therapeutics, LLC

Glycopyrrolate Tablets (Par) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Class IIModerate

FDAMar 30, 2020Nationwide• Par Pharmaceutical Inc.

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