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Showing 10401–10420 of 14370 results

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Stock TPN D10% (Central Admixture) - Non-Sterile Contamination (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

TPN Dextrose 5% (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal Starter 10% Dextrose (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Neonate D10 Bridge (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

TPN Neonatal Starter (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

TPN Neonatal Starter (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal Starter (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Virtua West Jersey TPN (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Texas Presbyterian TPN (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Adventist Hinsdale Neonatal (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Neonate TPN Starter Bag (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal Starter 5% Dextrose (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Spotsylvania TPN Neonatal (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

Rose Medical Neonate D5 (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

UAB TPN Neonatal Starter (Central Admixture) – Microbial Risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

NICU TPN Starter (Central Admixture) - non-sterile risk (2014)

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

FDADec 17, 2014Nationwide• Central Admixture Pharmacy Services, Inc.

J-TAN D PD Drops (Jaymac) - Mislabeled Dye Content (2014)

Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.

Class IIModerate

FDADec 16, 2014AR, LA, MS +1 more• Jaymac Pharmaceuticals L.L.C.

Gabapentin Capsules 400mg (Actavis) - Capsule Defect (2014)

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Class IIModerate

FDADec 15, 2014PR• Actavis Elizabeth LLC

Gabapentin Capsules 300mg (Actavis) - Capsule Defect (2014)

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Class IIModerate

FDADec 15, 2014PR• Actavis Elizabeth LLC

Gabapentin Capsules 100mg (Actavis) - Capsule Defect (2014)

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Class IIModerate

FDADec 15, 2014PR• Actavis Elizabeth LLC

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