Pravastatin Sodium 20mg Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets, USP, 20mg, 90-count bottles (Lot # 17230810, expiration Mar-26) nationwide due to manufacturing process deviations.
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: FDA Class II classification applies. The source describes CGMP deviations but reports no illnesses or injuries, making this a precautionary manufacturing-compliance recall rather than a safety incident.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets, USP, 20mg, in 90-count bottles distributed nationwide. The recall affects product manufactured for Northstar Rx LLC, Memphis, TN, with NDC# 16714-559-01. The affected lot is Lot # 17230810 with an expiration date of March 2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. This is a Class II recall, meaning the product is unlikely to cause adverse health consequences but warrants action to prevent potential harm.
Patients taking this medication should contact their pharmacy or healthcare provider. The recall was initiated on March 13, 2025, and classified by the FDA on April 8, 2025. For more information, consult the FDA's drug recall database or contact Glenmark Pharmaceuticals Inc., USA.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription
- 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 # 17230810
- exp. date Mar-26
UPCs (3)
- 0316714570013
- 0316714559018
- 0316714560014
Distribution
Distributed nationwide across the United States.
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