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Showing 1981–2000 of 14370 results

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TIROSINT-SOL Levothyroxine Solution 200mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 13mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 25mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 100mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 125mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 150mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

Tirosint-SOL (IBSA) - Subpotent Drug (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 88mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

TIROSINT-SOL Levothyroxine Solution 50mcg (IBSA) – Subpotent (2023)

Subpotent Drug

Class IIModerate

FDAJan 30, 2023Nationwide• IBSA PHARMA INC

Verapamil Hydrochloride Tablets (Amerisource) - Failed Dissolution (2023)

Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.

Class IIModerate

FDAJan 27, 2023Nationwide• Amerisource Health Services LLC

Clobetasol Propionate Cream (Lupin) - Subpotent Drug (2023)

Subpotent Drug: Low assay result observed during long-term stability testing.

FDAJan 20, 2023Nationwide• Lupin Pharmaceuticals Inc.

Allopurinol Tablets (Preferred) - Foreign Substance (2023)

Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Class IIModerate

FDAJan 16, 2023IN• Preferred Pharmaceuticals, Inc.

Diltiazem Hydrochloride Capsules (Sun) - Impurity Failure (2023)

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Class IIModerate

FDAJan 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

FentaNYL Citrate Injection (OurPharma) - Short Fill (2023)

Short Fill: Underfilled units.

FDAJan 13, 2023IL, MO• OurPharma LLC

Allopurinol Tablets (Accord) - Foreign Substance (2023)

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Class IIModerate

FDAJan 12, 2023Nationwide• Accord Healthcare, Inc.

Sterile Water Injection (Nephron) - CGMP Issue (2023)

CGMP Deviations: potential for trace amounts of product carryover.

Class IIModerate

FDAJan 12, 2023Nationwide• Nephron Sc Inc

Sodium Chloride Injection (Nephron) - CGMP Issue (2023)

CGMP Deviations: potential for trace amounts of product carryover.

Class IIModerate

FDAJan 12, 2023Nationwide• Nephron Sc Inc

Fiber Powder (Ortho Molecular) - bacterial contamination (2023)

Raw material tested positive for Cronobacter sakazakii.

Class IIModerate

FDAJan 12, 2023Nationwide• Ortho Molecular Products, Inc.

Rocuronium Bromide Injection (Nephron) - Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 6, 2023Nationwide• Nephron Sterile Compounding Center LLC

Metoprolol Succinate Tablets (Ascend) - Dissolution Failure (2023)

Failed Dissolution Specification

Class IIModerate

FDAJan 5, 2023Nationwide• Ascend Laboratories, LLC

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