Drug recall: Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-c
FDA enforcement event 84657 is a drug recall by Denton Pharma, Inc. of North Blenheim, NY, initiated 20 Dec 2019 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 5 Oct 2023. Initiation: voluntary: firm initiated. Denton Pharma, Inc. has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Denton Pharma, Inc., North Blenheim, NY.
Reason for recall
"CGMP Deviations: Presence of NDMA impurity detected in product."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0794-2020 | Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131. | 1,341 bottles | Class II | Terminated | 29 Jan 2020 |
| D-0795-2020 | Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131 | 467 bottles | Class II | Terminated | 29 Jan 2020 |
Context
Other enforcement events for Denton Pharma, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Oct 2020 | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged | Drug | Class II | 2 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Presence of NDMA impurity detected in product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.