Class II · Moderate risk Terminated
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701…
Reason cGMP Deviations
Is Ropinirole recalled?
13 FDA recalls mention Ropinirole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ropinirole.
Class II · Moderate risk Terminated
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx…
Reason cGMP deviations
Class II · Moderate risk Terminated
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct…
Reason cGMP deviations
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz…
Reason Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence…
Class II · Moderate risk Terminated
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan…
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…
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