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Breckenridge Pharmaceutical, Inc

Breckenridge Pharmaceutical, Inc Recalls

All product recalls associated with Breckenridge Pharmaceutical, Inc.

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

34

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1261–1280 of 4747 recalls

Omeprazole Capsules (Breckenridge) – impurity specifications (2021)

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

Class IIModerate

FDAMar 11, 2021Nationwide• Breckenridge Pharmaceutical, Inc

ZOMA-Jet 10 Demonstration Kit (Ferring) – Injector Defect (2021)

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Class IIModerate

FDAMar 11, 2021Nationwide• Ferring Pharmaceuticals Inc

ZOMA-Jet 5 Demonstration Kit (Ferring) – Injector Defect (2021)

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

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Class IIModerate

FDAMar 11, 2021Nationwide• Ferring Pharmaceuticals Inc

Phenylephrine Injection (Sagent) – sterility risk (2021)

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

Class IIModerate

FDAMar 11, 2021Nationwide• Sagent Pharmaceuticals Inc

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - U...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN ...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i with Single Aspirate Autosampler (SMN 1048892...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, au...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, a...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 1121953...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, ...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, au...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US,...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Romidepsin Injection (Teva) – impurity specifications (2021)

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

FDAMar 4, 2021Nationwide• Teva Pharmaceuticals USA

Siemens Healthcare Diagnostics, Inc.: BCS XP System: Multipurpose system for in vitro coagulati...

Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

FDAMar 2, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Menopur (Ferring) – pH specification failure (2021)

Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP

FDAMar 2, 2021Nationwide• Ferring Pharmaceuticals Inc

CAIRE DIAGNOSTICS INC: CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Produc...

Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.

FDAFeb 26, 2021Nationwide• CAIRE DIAGNOSTICS INC

EPIX THERAPEUTICS, INC: EPIX Therapeutics DiamondTemp Unidirectional Small Curve ...

It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

FDAFeb 22, 2021IN• EPIX THERAPEUTICS, INC

Cequa Ophthalmic Solution (Sun Pharma) – subpotent (2021)

Subpotent

FDAFeb 22, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC