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Showing 14461–14480 of 15081 results

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Test Cyp-Lidocaine Injection (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Tizanidine Tablets (Dr. Reddy's) – Labeling Issue (2013)

Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.

FDAMar 19, 2013Nationwide• Dr. Reddy'S Laboratories

Disulfiram Tablets (Teva) – Missing Cotton Coil (2013)

CGMP Deviation; cotton coil is missing in some packaged bottles

Class IIILow

FDAMar 19, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Piperacillin-Tazobactam Injection (Apotex) – Crystallization Risk (2013)

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

FDAMar 18, 2013Nationwide• Apotex Corp.

Ethambutol Tablets (West-ward) – Subpotent Medication (2013)

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

Class IIModerate

FDAMar 18, 2013Nationwide• West-ward Pharmaceutical Corp.

Ferrous Sulfate Tablets (Magno Humphries) – plastic contamination (2013)

The firm found minute pieces of blue material identified by their raw material supplier as polypropylene, a relatively inert plastic.

FDAMar 18, 2013Nationwide• Magno Humphries Inc

Camila Tablets (Physicians Total Care) – Impurity Detected (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 18, 2013MO• Physicians Total Care, Inc.

Oxcarbazepine Tablets (Boehringer Ingelheim) – Subpotent Drug (2013)

SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

FDAMar 18, 2013Nationwide• Boehringer Ingelheim Roxane Inc

Donnatal Extentabs (West-ward) – Incorrect Labeling (2013)

Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.

Class IIModerate

FDAMar 18, 2013Nationwide• West-ward Pharmaceutical Corp.

Junel Fe Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Errin Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Camila Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Lessina Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Balziva Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Jolessa Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Combat Powder (Musclepharm) – Packaging Contamination (2013)

One lot of each product may have extraneous materials due to a problem on the packing line.

Class IIModerate

FDAMar 14, 2013AR, CA, CO +11 more• F.H.G Corporation dba Integrity Nutraceuticals

Combat Powder (Integrity Nutraceuticals) – packaging contamination (2013)

One lot of each product may have extraneous materials due to a problem on the packing line.

Class IIModerate

FDAMar 14, 2013AR, CA, CO +11 more• F.H.G Corporation dba Integrity Nutraceuticals

Compounded Products (Med Prep) – Sterility Concern (2013)

Lack of Assurance of Sterility; potential for mold contamination

Class IIModerate

FDAMar 14, 2013Nationwide• Med Prep Consulting, Inc.

Camrese Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

FDAMar 14, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Seasonale Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

FDAMar 14, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

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