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Showing 681–700 of 3363 results

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Wheat Gluten (Able Sales) – chemical contamination (2022)

Traces of 2-chloro-ethanol (2-CE) in wheat gluten.

Class IIILow

FDAApr 5, 2022PR• Able Sales Company, Inc.

Cyanocobalamin Injection (Aurobindo) – Subpotent Drug (2022)

Subpotent Drug: Out of Specification results for Assay

Class IIILow

FDAApr 5, 2022Nationwide• Aurobindo Pharma USA Inc.

Sodium Chloride Injection (Ritedose) – Incorrect Barcode (2022)

Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.

Class IIILow

FDAApr 1, 2022Nationwide• The Ritedose Corporation

Methylprednisolone Tablets (Jubilant Cadista) – Subpotent Medication (2022)

Subpotent

Class IIILow

FDAApr 1, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Cequa Cyclosporine (Sun Pharmaceutical) – Subpotent Medication (2022)

Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.

Class IIILow

FDAApr 1, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Wal-Tussin DM (AptaPharma) – Undeclared Alcohol (2022)

Undeclared Allergen

Incorrect/Undeclared Excipient: Product contains alcohol

Class IIILow

FDAMar 29, 2022IL• AptaPharma Inc.

NETSPOT Dotatate Kit (Advanced Accelerator) – Subpotent Drug (2022)

Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

Class IIILow

FDAMar 18, 2022Nationwide• Advanced Accelerator Applications USA, Inc.

Atorvastatin Tablets (Dr. Reddy's) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

Class IIILow

FDAMar 16, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Risedronate Sodium Tablets (Macleods) – Content Uniformity Failure (2022)

FAILED CONTENT UNIFORMITY SPECIFICATIONS

Class IIILow

FDAMar 10, 2022Nationwide• Macleods Pharma Usa Inc

Caesar Dressing (Sauer Brands) – Undeclared Soy (2022)

Undeclared Allergen

Undeclared Allergen - Soy

Class IIILow

FDAMar 10, 2022AZ, CA, CO +12 more• Sauer Brands Inc - New Century

SB-4 Injection (Olympia Pharmacy) – Sub Potent (2022)

Sub Potent

Class IIILow

FDAMar 8, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Hydroxocobalamin B12 (Olympia Pharmacy) – Sub Potent (2022)

Sub Potent

Class IIILow

FDAMar 8, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

T-105 Injection (Olympia Pharmacy) – Super Potent (2022)

Super Potent

Class IIILow

FDAMar 8, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Formula F9 Injection (Olympia Pharmacy) – Sub Potent (2022)

Sub Potent

Class IIILow

FDAMar 8, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Marine Corps Mash (HumbleHungryHappy) – Unspecified Fish Species (2022)

Contains statement declares Fish but does not specify the name of fish.

Class IIILow

FDAMar 7, 2022IN, OR• HumbleHungryHappy LLC

Bison Breakfast (HumbleHungryHappy) – unspecified fish (2022)

Contains statement declares Fish but does not specify the name of fish.

Class IIILow

FDAMar 7, 2022IN, OR• HumbleHungryHappy LLC

Bison Shepherd's Pie (HumbleHungryHappy) – unspecified fish (2022)

Contains statement declares Fish but does not specify the name of fish.

Class IIILow

FDAMar 7, 2022IN, OR• HumbleHungryHappy LLC

Nandrolone Decanoate (Fagron) – subpotent drug (2022)

Subpotent Drug

Class IIILow

FDAMar 4, 2022Nationwide• Fagron, Inc

Nandrolone Decanoate (Fagron) – subpotent drug (2022)

Subpotent Drug

Class IIILow

FDAMar 4, 2022Nationwide• Fagron, Inc

Nandrolone Decanoate (Fagron) – subpotent drug (2022)

Subpotent Drug

Class IIILow

FDAMar 4, 2022Nationwide• Fagron, Inc

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