Food, drugs, devices › Novitium Pharma LLC
Drug recall: Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East
FDA enforcement event 84147 is a drug recall by Novitium Pharma LLC of East Windsor, NJ, initiated 25 Oct 2019 and classified Class II, with 4 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 17 Mar 2021. Initiation: voluntary: firm initiated. Novitium Pharma LLC has 3 enforcement events on this register, with a median of 1 product record 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
Novitium Pharma LLC, East Windsor, NJ.
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-0310-2020 | Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20 | 19560 bottles | Class II | Terminated | 20 Nov 2019 |
| D-0311-2020 | Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40 | 2718 bottles | Class II | Terminated | 20 Nov 2019 |
| D-0312-2020 | Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10 | 12312 bottles | Class II | Terminated | 20 Nov 2019 |
| D-0313-2020 | Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40 | 6660 bottles | Class II | Terminated | 20 Nov 2019 |
Context
Other enforcement events for Novitium Pharma LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Mar 2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Dri | Drug | Class III | 1 |
| 4 Mar 2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Driv | Drug | Class III | 1 |
All 3 events for Novitium Pharma LLC
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 17 Mar 2021. "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.