FDA Drug recall D-0645-2020
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01
- FDA Drug
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01 by Aaa Pharmaceutical, citing CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0645-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-26 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aaa Pharmaceutical |
| Distribution | n/a |
Product
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Identifiers
| code_info | P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 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-0645-2020%22
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