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Drug recalls

Drug recalls from FDA, newest first.
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3 recalls

Adequan Canine and Equine Injections

Adequan Canine and Adequan i.m. injections contain glass fibers that may cause irritation, swelling, or infection.

Moderate risk, FDA, Contamination

Optiray Imaging Bulk Package-350, Ioversol Injection 74%

Optiray Imaging Bulk Package-350 contains particulate matter including plastic and glass, which may cause local irritation or swelling.

High risk, FDA, Foreign object

Parnell Sevoflurane Inhalation Anesthetic for Dogs

Sevoflurane inhalation solution has a bottle collar notch pattern incompatible with the sevoflurane-specific anti-spill pour spout.

FDA

1 recall

Glenmark Azelaic Acid Gel

Azelaic Acid Gel, 15%, 50 gram tubes may have abnormal texture or consistency described as grainy, gritty, or sandy.

Moderate risk, FDA, Manufacturing problem

7 recalls

Long Grove Pharmaceuticals Cyclophosphamide for Injection

Cyclophosphamide for Injection contains stainless steel particulate matter that can cause serious adverse events, including death.

High risk, FDA, Foreign object

Baxter Cefazolin in Dextrose Injection

Cefazolin in Dextrose Injection may contain particulate matter, which can cause pulmonary emboli, blood vessel occlusions, and phlebitis.

High risk, FDA, Foreign object

American Regent Nitroglycerin, Cyanocobalamin, Aminocaproic Acid, Atropine Sulfate, Acetylcysteine, Selenious Acid, Multrys, Papaverine HCl, Tralement and Nicardipine Injections

American Regent injections contain particulate matter.

High risk, FDA, Contamination

Micro Labs Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution has defective container caps that may break.

Moderate risk, FDA, Packaging defect

Proin ER, Phenylpropanolamine Hydrochloride Extended-Release Tablets

Proin ER tablets failed dissolution specifications, which can affect drug release.

Moderate risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran Etexilate Capsules failed impurity and degradation specifications.

Low risk, FDA, Drug impurity

Mylan Mycophenolate Mofetil for Injection

Mycophenolate Mofetil for Injection USP contains a precipitate.

Moderate risk, FDA, Quality problem

3 recalls

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections contain particulate matter.

Moderate risk, FDA, Foreign object

Rohto Cooling Eye Drops

Rohto Cooling Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Precision Dose Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution failed impurities and degradation specifications due to an unidentified impurity.

Moderate risk, FDA, Drug impurity

1 recall

Rising Pharma Cetirizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets may be contaminated with ranitidine, which could cause serious reactions.

High risk, FDA, Contamination

7 recalls

Rising Cyproheptadine Hydrochloride Syrup

Cyproheptadine Hydrochloride Syrup has crystallized and particles floating in the bottle.

Moderate risk, FDA, Foreign object

Major Pharmaceuticals Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets failed dissolution specifications, with Olmesartan Medoxomil content below specifications.

Moderate risk, FDA, Drug dissolving problem

Trokendi XR, Topiramate Extended-Release Capsules

Trokendi XR, topiramate extended-release capsules failed dissolution specifications.

Low risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran etexilate capsules failed impurity and degradation specifications during stability testing.

Low risk, FDA, Drug impurity

Bionpharma Divalproex Sodium Delayed-Release Tablets

Divalproex Sodium Delayed-Release Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

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

5 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 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

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

3 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

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

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

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

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

5 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

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

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