Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Atorvastatin Calcium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Affected NDC
63304-0829-05
Compare with the code on your package — it is the most precise check available.
Drug: Atorvastatin 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 |
|---|---|---|---|---|
| Atorvastatin Calcium NDC 63304-0829 |
TRIHYDRATE 40 mg/1 | Tablet, Film Coated Oral |
Sun Pharmaceutical Industries Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- NDC code
- 63304-829-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1047-2020 · 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.
Other Atorvastatin recalls
See all
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Other recalls by Sun Pharmaceutical Industries, Inc.
All 2020 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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