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Showing 2001–2020 of 14370 results

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Metoprolol Succinate Tablets (Ascend) – Failed Dissolution (2023)

Failed Dissolution Specification

Class IIModerate

FDAJan 5, 2023Nationwide• Ascend Laboratories, LLC

Levofloxacin Tablets (Macleods) – Embossing Mismatch (2023)

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

FDAJan 5, 2023Nationwide• MACLEODS PHARMA USA, INC

Metoprolol Succinate Tablets (Ascend) – Failed Dissolution (2023)

Failed Dissolution Specification

Class IIModerate

FDAJan 5, 2023Nationwide• Ascend Laboratories, LLC

SINUVA Sinus Implant (Intersect ENT) – Failed Dissolution (2023)

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

FDAJan 4, 2023Nationwide• Intersect ENT, Inc.

TriMix Original PGE1/Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Prostaglandin E1 Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

QuadMix Standard 002 (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Prostaglandin E1 Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

QuadMix Standard PGE1/Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

BiMix STD 001 (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Prostaglandin (E1) Injection 40mcg/ml (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection PGE1/Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

QuadMix Injectable (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

BiMix Injection Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

QuadMix Injectable (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Prostaglandin (E1) Injection 25mcg/ml (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

QuadMix Super 001 (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Plus 002 (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

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