FDA Drug recall D-1038-2017
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx…
- FDA Drug
- Class III
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class III recall of Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx… by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1038-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-07-11 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Reason
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Identifiers
| ndc | 55111-229-30 |
|---|---|
| ndc | 55111-229-90 |
| ndc | 55111-229-01 |
| ndc | 55111-229-05 |
| ndc | 55111-230-30 |
| ndc | 55111-230-90 |
| ndc | 55111-230-01 |
| ndc | 55111-230-05 |
| ndc | 55111-231-30 |
| ndc | 55111-231-90 |
| ndc | 55111-231-01 |
| ndc | 55111-231-05 |
| ndc | 55111-274-30 |
| ndc | 55111-274-90 |
| ndc | 55111-274-01 |
| ndc | 55111-274-05 |
| code_info | Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1038-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.