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Lidocaine HCl 2% (Pharmedium) – Potency Loss (2015)

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Bupropion Hydrochloride Tablets (Sun Pharma) – dissolution failure (2015)

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Class IIILow

FDAJul 17, 2015Nationwide• Sun Pharma Global Fze

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Lidocaine HCl 2% (Pharmedium) – Potency Loss (2015)

Bupropion Hydrochloride Tablets (Sun Pharma) – dissolution failure (2015)

Lidocaine HCl 2% Injection (Pharmedium) – potency loss (2015)

Morphine Sulfate (Pharmedium) – Potency Loss (2015)

Lidocaine HCl 1% (Pharmedium) – Potency Loss (2015)

PHENYLephrine HCl 100 mcg (Pharmedium) – Potency Loss (2015)

Midazolam HCl Injection (Pharmedium) – potency loss (2015)

Hydromorphone HCl (Pharmedium) – Potency Loss (2015)

Ketamine HCl (Pharmedium) – Potency Loss (2015)

Midazolam HCl (Pharmedium) – Potency Loss Risk (2015)

Ketamine HCl 10 mg (Pharmedium) – Potency Loss (2015)

Methadone HCl 1 mg (Pharmedium) – Potency Loss (2015)

Fentanyl Citrate Injection (Pharmedium) – potency loss (2015)

ePHEDrine Sulfate 10 mg (Pharmedium) – Potency Loss (2015)

Morphine Sulfate Injection (Pharmedium) – potency loss (2015)

Sodium Chloride Injection (Baxter) – insect contamination (2015)

Sodium Chloride Injection (Baxter) – insect contamination (2015)

HYDROmorphone HCl 0.2 mg (Pharmedium) – Potency Loss (2015)

Methadone HCl (Pharmedium) – Potency Loss (2015)

Lidocaine HCl (Pharmedium) – Potency Loss Risk (2015)