Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Class I - Dangerous
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Baxter Healthcare
Class I - Dangerous
cGMP Deviation
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I - Dangerous
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Mylan Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I - Dangerous
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I - Dangerous
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
Mylan Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class I - Dangerous
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
Avkare Incorporated
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
Avkare Incorporated
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
Avkare Incorporated
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.