June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India ND
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India ND
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Phar
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, In
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad,
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedab
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmeda
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distribut
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Preferred Pharmaceuticals, Inc recalls Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg
Hazard: CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 26, 2019DrugsFDA
P & L Developments, LLC recalls Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (
Hazard: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 26, 2019DrugsFDA
P & L Developments, LLC recalls Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distribut
Hazard: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 26, 2019DrugsFDA
P & L Developments, LLC recalls Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL,
Hazard: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
June 26, 2019DrugsFDA
American Health Packaging recalls Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American H
Hazard: GMP Deviations: Potential cross contamination due to cleaning procedure failure.
June 26, 2019DrugsFDA
Ecolab Inc recalls QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Pa
Hazard: Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
June 26, 2019DrugsFDA
Akorn Inc recalls Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, R
Hazard: Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
June 26, 2019DrugsFDA
Teligent Pharma, Inc. recalls Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019
Hazard: Failed Impurities/Degradation Specifications
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-co
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-c
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Dis
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 26, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distr
Hazard: Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
June 19, 2019DrugsFDA
Geritrex, LLC recalls Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown,
Hazard: Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
June 19, 2019DrugsFDA
Geritrex, LLC recalls Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middle
Hazard: Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
June 19, 2019DrugsFDA
Baxter Healthcare Corporation recalls Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield
Hazard: Failed Stability Specifications
June 19, 2019DrugsFDA
Synthetopes Inc recalls Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, In
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Synthetopes Inc recalls Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Hazard: Lack of Processing Controls.
June 19, 2019DrugsFDA
Synthetopes Inc recalls Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Hazard: Lack of Processing Controls.