Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN…
Reason CGMP Deviations
Is Propafenone recalled?
6 FDA recalls mention Propafenone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Propafenone.
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals…
Reason CGMP Deviations
Class III · Low risk Terminated
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson…
Reason Failed moisture limits: Out of specification for moisture content.
Class II · Moderate risk Terminated
PROPAFENONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591058201.
Reason Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10…
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