Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class I - Dangerous
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
Kremers Urban Pharmaceuticals
Class I - Dangerous
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
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, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Class I - Dangerous
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Class I - Dangerous
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 U.S.A., NDC 0378-6900-01
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Amneal Pharmaceuticals of New York
Class I - Dangerous
Failed dissolution specifications; 18 month CRT
Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01
Mylan Pharmaceuticals
Class I - Dangerous
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.S.A., NDC 0378-6899-01
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
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
Mylan Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.