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Brimonidine Tartrate Ophthalmic (Somerset) – Label Leaching Risk (2020)

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Class IIILow

FDAJun 4, 2020Nationwide• SOMERSET THERAPEUTICS LLC

Brimonidine Tartrate Ophthalmic (Somerset) – Label Leaching Risk (2020)

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Class IIILow

FDAJun 4, 2020Nationwide

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Brimonidine Tartrate Ophthalmic (Somerset) – Label Leaching Risk (2020)

Brimonidine Tartrate Ophthalmic (Somerset) – Label Leaching Risk (2020)

Brimonidine Tartrate Ophthalmic (Somerset) – Label Leaching Risk (2020)

Metformin Hydrochloride Extended-Release (Teva) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release (Teva) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

Unasyn Injection (Pfizer) – Particulate Matter (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

Lamotrigine Tablets (AVKARE) – Foreign Substance (2020)

Oxytocin Injection (QuVa Pharma) – Subpotent Drug (2020)