Atorvastatin Calcium Tablets recalled over foreign material
- Recall date
- May 30, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam…
- Recall number
- D-0878-2018
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
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