Drug Recall: Propafenone Hydrochloride Capsules Due to Manufacturing Deviations
Glenmark Pharmaceuticals has voluntarily recalled Propafenone Hydrochloride Extended-Release Capsules (225mg, lot 17230819) due to manufacturing quality control deviations. The recall affects product distributed nationwide in the United States.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall, indicating potential for harm. No illnesses or injuries have been reported. The CGMP deviation on a prescription cardiac medication represents a risk-of-harm product without reported injury, meeting the threshold for High severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA has initiated a nationwide voluntary recall of Propafenone Hydrochloride Extended-Release Capsules USP, 225mg, with lot number 17230819 and expiration date March 2025. The product is manufactured by Glenmark Pharmaceuticals Limited in India.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this product.
The affected lot was distributed nationwide in the United States. Patients and healthcare providers should verify the lot number on their medication to determine if they are affected.
Patients taking this medication should contact their healthcare provider before stopping or changing their treatment. Adverse events can be reported to FDA MedWatch at 1-888-SAFEMEDS or through www.fda.gov/medwatch.
The recalled product
- Product
- PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
- Brand
- PROPAFENONE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 17230819
- exp. date Mar-25
UPCs (3)
- 0316714826011
- 0316714827018
- 0316714825014
Distribution
Distributed nationwide across the United States.
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- HighPrescription Cardiac Drug Recalled for Manufacturing Quality Deviations Nationwide
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