FDA Drug recall D-1004-2020
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62
- FDA Drug
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62 by Precision Dose, citing CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1004-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-13 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Precision Dose |
| Distribution | US |
Product
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Identifiers
| code_info | Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61; Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62;…Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61; Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62; Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62 |
|---|
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-1004-2020%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.