FDA Drug recall D-0826-2020
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14)
- FDA Drug
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14) by Pd Rx Pharmaceuticals, citing CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0826-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-10 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN |
Product
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Reason
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Identifiers
| code_info | a) H19E83 Exp. 11/30/2020, E19A82 Exp. 05/31/2020; b) H19B20 Exp. 11/30/2020, G19D77 Exp. 05/31/2020, C19D84 Exp. 05/31…a) H19E83 Exp. 11/30/2020, E19A82 Exp. 05/31/2020; b) H19B20 Exp. 11/30/2020, G19D77 Exp. 05/31/2020, C19D84 Exp. 05/31/2020, D19A77 Exp. 05/31/2020, D19E40 Exp. 05/31/2020; c) I19C45 Exp. 11/30/2020, E19E42 Exp. 11/30/2020, G19B41 Exp. 11/30/2020, H19C77 Exp. 11/30/2020, E19A34 Exp. 05/31/2020; d) H19B61 Exp. 11/30/2020, H19C82 Exp. 11/30/2020, C19A18 Exp. 05/31/2020, C19B13 Exp. 05/31/2020, D19B77 Exp. 05/31/2020, E19B76 Exp. 05/31/2020; e) I19B41 Exp. 11/30/2020, D19D51 Exp. 05/31/2020, F19C33 Exp. 05/31/2020 |
|---|
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-0826-2020%22
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