Freedom Pharmaceuticals Inc Recalls

FDAJan 8, 2015Nationwide• Freedom Pharmaceuticals Inc

Glycopyrrolate Injection (SCA Pharmaceuticals) – Labeling Error (2015)

Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".

FDAJan 2, 2015LA• SCA Pharmaceuticals

Virazole (Valeant) – Non-sterile contamination (2014)

Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.

Class II

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Moderate

FDADec 31, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Children's Loratadine Syrup (Taro) – Blue plastic found (2014)

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

FDADec 30, 2014Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Siemens Healthcare Diagnostics Inc: RAPIDLab 1265 System; Siemens Material Number: 10491395,...

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RAPIDLab 1245 System; Siemens Material Number: 10321844,...

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Numbe...

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc: RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Numbe...

FDADec 30, 2014Nationwide• Siemens Healthcare Diagnostics Inc

Ortho-Clinical Diagnostics: VITROS Hand-held Barcode Scanner, Catalog Number 6844210,...

In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended.

FDADec 29, 2014Nationwide• Ortho-Clinical Diagnostics

Benzonatate Capsules (Zydus Pharmaceuticals) – Wet Capsules (2014)

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

FDADec 23, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Acetaminophen Codeine Solution (Qualitest) – Impurity Concern (2014)

Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

FDADec 22, 2014Nationwide• Qualitest Pharmaceuticals

Roche Diagnostics Operations, Inc.: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes...

Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.

FDADec 18, 2014Nationwide• Roche Diagnostics Operations, 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.

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

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry XPT interfaced to the CentraLink Data Ma...

Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.

FDADec 16, 2014IN, WA• Siemens Healthcare Diagnostics, Inc.

Genetic Testing Institute,inc: PF4 Concentrated Wash (10x), REF 403624, packaged in the ...

Laceration Risk

Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.

FDADec 15, 2014Nationwide• Genetic Testing Institute,inc

Eye Drops Industrial Strength (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Eye Drops (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Eye Drops Advanced Relief (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Eye Drops A.C. (K C Pharmaceuticals) – Non-Compliant Storage (2014)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Iris Diagnostics: RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpi...

Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.