Food, drugs, devices › AAA Pharmaceutical, Inc.
Drug recall: Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
FDA enforcement event 84583 is a drug recall by AAA Pharmaceutical, Inc. of Lumberton, NJ, initiated 26 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 10 Mar 2021. Initiation: voluntary: firm initiated. AAA Pharmaceutical, Inc. 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
AAA Pharmaceutical, Inc., Lumberton, NJ.
Reason for recall
"CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API"
Distribution
"Product was distributed to one consignee who may have distributed the product further to their retail stores."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0645-2020 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. | 34,272 (24-count bottles) | Class II | Terminated | 15 Jan 2020 |
| D-0646-2020 | Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. | 31,536 (130-count bottles) | Class II | Terminated | 15 Jan 2020 |
Context
Other enforcement events for AAA Pharmaceutical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Feb 2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, | Drug | Class III | 1 |
| 25 Jun 2019 | Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83 | Drug | Class III | 1 |
All 3 events for AAA Pharmaceutical, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API"
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: "Product was distributed to one consignee who may have distributed the product further to their retail stores."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 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.