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Showing 9541–9560 of 14370 results

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Succinylcholine Chloride Injection (Pharmedium) – potency loss (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Buffered Lidocaine Injection (Pharmedium) – potency loss (2015)

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

Class IIModerate

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.

FDAJul 17, 2015Nationwide• Sun Pharma Global Fze

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Heparin Sodium Injection (Pharmedium) – potency loss (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Lidocaine HCl 1% Injection (Pharmedium) – potency loss (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Hydromorphone HCl (Pharmedium) – Potency Loss (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Fentanyl Citrate (Pharmedium) – Subpotent Drug (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Morphine Sulfate (Pharmedium) – Potency Loss (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Glycopyrrolate (Pharmedium) – Potency Loss (2015)

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

Class IIModerate

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

Fentanyl Citrate (Pharmedium) – Subpotent Drug (2015)

Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.

FDAJul 17, 2015Nationwide• Pharmedium Services, LLC

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