Propafenone Hydrochloride Extended-Release Capsules Recalled for Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg nationwide due to Current Good Manufacturing Practice deviations. No illness or injury has been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II drug recall initiated voluntarily by the manufacturer for manufacturing practice deviations, with no reported illness or injury. It is classified as a precautionary recall and receives a Moderate severity rating.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg, supplied in 60-count bottles. The product is a prescription medication. The affected product includes NDC# 68462-409-60 and related package numbers, manufactured at Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India.
The firm initiated this voluntary recall following the identification of Current Good Manufacturing Practice (CGMP) deviations during manufacturing. This is a Class II recall. No illness or injury has been reported in connection with this product.
The affected product was distributed nationwide across the United States. The recall specifically affects lot 17230767 with expiration date March 2025. Patients currently using Propafenone Hydrochloride from the recalled lot should contact their pharmacy or healthcare provider to determine whether they have affected product and to discuss next steps.
The recalled product
- Product
- PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
- Brand
- PROPAFENONE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- cgmp-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 # 17230767
- exp. date Mar-25
UPCs (3)
- 0368462409602
- 0368462410608
- 0368462408605
Distribution
Distributed nationwide across the United States.
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