FDA Drug recall D-0878-2018
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd
- FDA Drug
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd by Dr Reddy S Laboratories, citing presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0878-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-30 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
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
Reason
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Identifiers
| upc | 355111124900 |
|---|---|
| ndc | 55111-124-30 |
| ndc | 55111-124-60 |
| ndc | 55111-124-90 |
| ndc | 55111-124-05 |
| ndc | 3551111249 |
| code_info | Lot #: T800064, Exp 12/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0878-2018%22
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