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Drug recalls

Drug recalls from FDA, newest first.
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9 recalls

LifeSouth Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

Versiti Blood Health Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet pH specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

1 recall

BD ChloraPrep Clear

BD ChloraPrep Clear may have an open or incomplete seal on the applicator packaging.

Moderate risk, FDA, Sterility problem

2 recalls

Chiesi Cleviprex Clevidipine Injectable Emulsion

Cleviprex injectable emulsion lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Bell Pharmaceuticals Carbamide Peroxide Ear Drops

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Moderate risk, FDA, Wrong drug strength

6 recalls

Padagis Nystatin Cream

Nystatin Cream USP is subpotent, with low assay results from stability testing.

Moderate risk, FDA, Wrong drug strength

Sun Pharmaceutical Fexofenadine Hydrochloride Tablets

Fexofenadine Hydrochloride Tablets failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without being labeled as containing red blood cell antibodies.

Low risk, FDA, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

4 recalls

Mississippi Blood Services Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced lack documentation of acceptable storage temperature.

Moderate risk, FDA

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

6 recalls

Somerset Therapeutics Pemetrexed, Bortezomib and Azacitidine for Injection

Pemetrexed, Bortezomib, and Azacitidine for Injection lack sterility assurance.

Moderate risk, FDA, Manufacturing problem

Gasco and Drogueria San Juan Isopropyl Alcohol

Isopropyl alcohol 70% is subpotent.

Moderate risk, FDA, Wrong drug strength

LifeServe Blood Center Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were manufactured with an unknown quantity of additive solution.

Low risk, FDA

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

8 recalls

Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Quality testing problem

QuVa Pharma Methohexital Sodium

Methohexital Sodium failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

Medline Remedy Specialized Silicone Cream (Hydraguard-D)

Medline Remedy Specialized Silicone Cream has formaldehyde levels exceeding specification.

Moderate risk, FDA, Quality testing problem

Shimoga Chemicals Clomiphene Citrate Active Pharmaceutical Ingredient

Clomiphene Citrate USP Active Pharmaceutical Ingredient has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Avet Methohexital Sodium for Injection

Methohexital Sodium for Injection failed impurities and degradation specifications.

Moderate risk, FDA, Drug impurity

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

3 recalls

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were not tested to verify white blood cell count.

Moderate risk, FDA, Quality testing problem

10 recalls

Cipla Cinacalcet Hydrochloride Tablets

CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Moderate risk, FDA, Drug impurity

Lannett Dextroamphetamine and Amphetamine Extended-Release Capsules

These capsules are labeled as extended-release but contain only immediate-release pellets.

Moderate risk, FDA, Labeling error

Enovachem Pharmaceuticals Lidocaine HCl Injection

Accucaine kits containing Lidocaine HCl Injection lack assurance of sterility.

Moderate risk, FDA, Sterility problem

The Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced did not meet yield specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count.

Moderate risk, FDA, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Platelets, Pathogen Reduced

Platelets, Pathogen Reduced did not meet specifications for platelet yield.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to an area endemic for malaria.

Moderate risk, FDA, Blood donor screening

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

2 recalls

Lupin Pharmaceuticals Glucagon Emergency Kit for Low Blood Sugar

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Moderate risk, FDA, Quality testing problem

Hikma Gemcitabine Injection

Gemcitabine Injection was stored incorrectly.

Moderate risk, FDA, Processing problem

7 recalls

Synjardy XR Tablets (Empagliflozin and Metformin Hydrochloride Extended-Release Tablets)

An incorrect detergent was used and required swab sampling was not performed on a production hopper.

Moderate risk, FDA, Manufacturing problem

Accord Healthcare Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

Lupin Prednisolone Acetate Ophthalmic Suspension

The ophthalmic suspension contains a foreign substance.

Moderate risk, FDA, Foreign object

The Blood Connection Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were not tested to verify white blood cell count.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem