Pravastatin Sodium Tablets Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling Pravastatin Sodium 20 mg tablets nationwide due to manufacturing practice deviations identified during FDA inspection. No illnesses have been reported.
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 Class II recall indicates potential adverse health consequences from manufacturing deviations identified during inspection. No reported illnesses or injuries.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottles (NDC 68788-8215-9), manufactured for Accord Healthcare, Inc., Durham, North Carolina. Twenty-four bottles have been recalled with a nationwide distribution in the United States.
The FDA initiated this Class II recall (D-0521-2023) following inspection findings of current good manufacturing practice (cGMP) deviations at Accord Healthcare. The specific manufacturing deviations were not detailed in available source materials.
Patients currently taking this medication should consult with their healthcare provider or pharmacist regarding their current supply. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- Affected units
- 24
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 (3)
- Lot: F1021I
- H3122J
- Exp 4/30/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Preferred Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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