DriectRx
NDC labeler code: 72189
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 31, 2023 | ANDA216800 | Bupropion BUPROPION HYDROCHLORIDE | Annora Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
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September 12, 2022 · Class II · Completed · D-1535-2022 · Triamcinolone acetonide
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
-
May 11, 2022 · Class II · Terminated · D-0894-2022 · Losartan potassium and hydrochlorothiazide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
-
May 11, 2022 · Class II · Terminated · D-0895-2022 · Losartan potassium and hydrochlorothiazide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
-
May 11, 2022 · Class II · Terminated · D-0893-2022 · Losartan potassium and hydrochlorothiazide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
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May 5, 2022 · Class II · Terminated · D-0971-2022 · Losartan potassium and hydrochlorothiazide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
2020
-
October 12, 2020 · Class II · Terminated · D-0058-2021 · Metformin hydrochloride
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026