Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Pravastatin Sodium Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Affected NDCs
16729-0008-15
16729-0008-16
Compare with the code on your package — it is the most precise check available.
Drug: Pravastatin Category: Cholesterol Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pravastatin Sodium NDC 16729-0008 |
10 mg/1 | Tablet Oral |
Accord Healthcare Inc. | Rx |
- Recalling firm
- Accord Healthcare, Inc.
- NDC code
- 16729-008-15
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0421-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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