Manufacturer profile
Cardinal Health 107, LLC
Pharmaceutical company6 products tracked
6
products tracked
384,679
total reports
220
recalls on record
75.0%
serious overall
Products
showing 6 of 6
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1995 | 206,980 | Chronic kidney disease | 100 | |
| 1995 | 87,627 | Chronic kidney disease | 100 | |
| 1990 | 35,427 | Hyperkalaemia | 16 | |
| 1967 | 24,303 | Neuroleptic malignant syndrome | 1 | |
| 2004 | 20,331 | Ammonia increased | 2 | |
| 2009 | 10,011 | Atrial fibrillation | 1 |
Recall history · 50 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Jan 21, 2026 | III | Tablets/Capsules Imprinted with Wrong ID | Unichem Pharmaceuticals USA Inc. |
| Dec 23, 2024 | II | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc |
| Dec 23, 2024 | II | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc |
| Apr 30, 2024 | II | Failed Impurities/Degradation Specifications | Viatris Inc |
| Apr 30, 2024 | II | Failed Impurities/Degradation Specifications | Viatris Inc |
| Jun 26, 2023 | II | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. | Strides Pharma Inc. |
| Mar 23, 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| Mar 20, 2023 | II | cGMP Deviations | RemedyRepack Inc. |
| Mar 16, 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| Feb 7, 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| Feb 7, 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| Feb 7, 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| Feb 7, 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| Jun 6, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. |
| Jun 6, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. |
| Jun 6, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. |
| May 18, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. |
| May 18, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. |
| May 18, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. |
| May 11, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx |
| May 11, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx |
| May 5, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Direct Rx |
| May 4, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | RemedyRepack Inc. |
| May 3, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Preferred Pharmaceuticals, Inc. |
| May 2, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. |
| May 2, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. |
| Apr 15, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc |
| Apr 15, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc |
| Apr 15, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc |
| Apr 15, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Macleods Pharma Usa Inc |
| Apr 12, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Preferred Pharmaceuticals, Inc. |
| Apr 6, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. |
| Mar 31, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. |
| Mar 31, 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. |
| Aug 6, 2020 | II | Failed Tablet/Capsule Specification; complaint of bulging tablet | Hetero Labs Limited (Unit V) |
| Apr 3, 2020 | II | CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. |
| Mar 26, 2020 | II | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Avet Pharmaceuticals, Inc. |
| Mar 26, 2020 | II | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Avet Pharmaceuticals, Inc. |
| Mar 25, 2020 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA |
| Mar 25, 2020 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA |
| Mar 25, 2020 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA |
| Sep 19, 2019 | II | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. | Torrent Pharma Inc. |
| Jun 20, 2019 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Macleods Pharma Usa Inc |
| Jun 14, 2019 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. |
| Jun 14, 2019 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. |
| Jun 14, 2019 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. |
| Jun 14, 2019 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. |
| Jun 6, 2019 | II | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Cardinal Health 107, LLC are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.