FDA Drug recall D-1120-2019
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd
- FDA Drug
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd by Glenmark Pharmaceuticals Usa, citing presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1120-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-25 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Reason
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Identifiers
| ndc | 68462-195-90 |
|---|---|
| ndc | 68462-195-05 |
| ndc | 68462-196-90 |
| ndc | 68462-196-05 |
| ndc | 68462-197-90 |
| ndc | 68462-197-05 |
| ndc | 68462-198-90 |
| ndc | 68462-198-05 |
| code_info | Lot 17181491 Exp. Aug. 2021 |
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-1120-2019%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.