Mylan Pharmaceuticals recalls
Mylan Pharmaceuticals appears in 84 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablet…
FDA Drug · Class III · 2017-05-31 · Mylan Pharmaceuticals
Reason: Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. - Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07)
FDA Drug · Class II · 2017-04-05 · Mylan Pharmaceuticals
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. - Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77)
FDA Drug · Class II · 2017-04-05 · Mylan Pharmaceuticals
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. - Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx on…
FDA Drug · Class II · 2017-04-05 · Mylan Pharmaceuticals
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. - Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07)
FDA Drug · Class II · 2017-04-05 · Mylan Pharmaceuticals
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. - Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
FDA Drug · Class II · 2017-03-15 · Mylan Pharmaceuticals
Reason: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle - glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
FDA Drug · Class II · 2017-03-08 · Mylan Pharmaceuticals
Reason: Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets - Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Man…
FDA Drug · Class III · 2016-11-30 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: OOS results for known compound. - Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
FDA Drug · Class II · 2016-05-18 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications; three month stability time point. - Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 037…
FDA Drug · Class II · 2015-07-15 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. - Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a)…
FDA Drug · Class III · 2015-04-15 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. - Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc
FDA Drug · Class II · 2014-10-15 · Mylan Pharmaceuticals
Reason: Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol - Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
FDA Drug · Class III · 2014-09-03 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. - Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only
FDA Drug · Class III · 2014-08-27 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. - Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2014-02-19 · Mylan Pharmaceuticals
Reason: Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification. - Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only,…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), R…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
FDA Drug · Class II · 2013-11-13 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. - Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Mo…
FDA Drug · Class II · 2013-06-05 · Mylan Pharmaceuticals
Reason: Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets.. - Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made i…
FDA Drug · Class III · 2013-05-01 · Mylan Pharmaceuticals
Reason: Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets.. - Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Mo…
FDA Drug · Class II · 2013-02-13 · Mylan Pharmaceuticals
Reason: Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets. - Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-…
FDA Drug · Class II · 2013-02-06 · Mylan Pharmaceuticals
Reason: Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. - Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx…
FDA Drug · Class II · 2012-10-31 · Mylan Pharmaceuticals
Reason: Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. - Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
FDA Drug · Class III · 2012-10-10 · Mylan Pharmaceuticals
Reason: Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing. - Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2012-10-03 · Mylan Pharmaceuticals
Reason: Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.