Table 1.
NDMA Amounts in metformin samples reported by FDA (using FDA-1 and FDA-2 methods) and the private laboratory
| Sample # | Metformin dosage and formulation | Manufacturer name as per private laboratory | Lot # | FDA-1a,b (ng/mg) | FDA-2 (ng/mg) | Private lab (ng/mg) |
|---|---|---|---|---|---|---|
| 1 | 500 mg IR | ACI Healthcare USA, Inc. | D105061 | NDc | ND | 0.062 |
| 2 | 500 mg IR | ACI Healthcare USA, Inc. | C105019A | ND | ND | ND |
| 3 | 500 mg IR | ACI Healthcare USA, Inc. | D105019 | ND | ND | ND |
| 4 | 500 mg ER | Actavis Pharma, Inc. | 1376339 M | 0.021d | 0.021 | 0.364 |
| 5 | 750 mg ER | Actavis Pharma, Inc. | 1354471A | 0.050 | 0.047 | 0.427 |
| 6 | 500 mg ER | Aiping Pharmaceutical, Inc. | 190300211 | ND | ND | ND |
| 7 | 1000 mg ER | Aiping Pharmaceutical, Inc. | 190200411 | ND | 0.008 d | ND |
| 8 | 1000 mg IR | Zydus | 184759 | ND | 0.006 d | ND |
| 9 | 750 mg ER | Amneal Pharmaceuticals, LLC | AM180770A | 0.079 | 0.076 | 0.600 |
| 10 | 500 mg ER | Amneal Pharmaceuticals, LLC | AM190107AA | 0.314 | 0.292 | 0.790 |
| 11 | 500 mg ER | Amneal Pharmaceuticals, LLC | HD03319A | 0.293 | 0.255 | 0.566 |
| 12 | 500 mg ER | Amneal Pharmaceuticals, LLC | HM02918A | 0.289 | 0.265 | 0.564 |
| 13 | 850 mg IR | Amneal Pharmaceuticals, LLC | AM180405A | ND | ND | 0.276 |
| 14 | 500 mg ER | Apotex Corp. | NE5801 | 0.121 | 0.112 | 0.180 |
| 15 | 750 mg ER | Apotex Corp. | NG2595 | ND | ND | ND |
| 16 | 1000 mg IR | Ascend Lab., LLC | 4200061B | ND | ND | 0.529 |
| 17 | 500 mg IR | Ascend Lab., LLC | 4980028B | ND | ND | ND |
| 18 | 1000 mg IR | Ascend Lab., LLC | 4200024C | ND | ND | ND |
| 19 | 500 mg IR | Aurobindo Pharma | MTSA19016-B | ND | ND | 0.060 |
| 20 | 500 mg IR | Aurobindo Pharma | MTSA19070-C | ND | ND | ND |
| 21 | 500 mg ER | Epic Pharma LLC | 190101111 | 0.010 d | 0.008 d | ND |
| 22 | 500 mg ER | Granules Pharma Inc | 4910134A | ND | ND | 0.082 |
| 23 | 850 mg IR | Heritage | 4510157A | ND | ND | 0.299 |
| 24 | 500 mg IR | Heritage | 4500753A | ND | ND | 0.412 |
| 25 | 1000 mg IR | Heritage | 4521630A | ND | ND | ND |
| 26 | 500 mg ER | Ingenus Pharmaceuticals | 19388005 | 0.012 d | 0.009 d | ND |
| 27 | 500 mg ER | Lupin Pharma | G901203 | 0.170 | 0.138 | 0.244 |
| 28 | 1000 mg IR | Megalith Pharmaceuticals | 442180318 | ND | ND | ND |
| 29 | 1000 mg ER | Mylan Pharmaceuticals | 3090719 | 0.011 d | 0.010 | ND |
| 30 | 1000 mg ER | Nostrum Labs Inc | MEF290206 | ND | ND | ND |
| 31 | 500 mg ER | Oceanside | 19D125P | 0.010 d | 0.005 d | ND |
| 32 | 750 mg ER | Sun Pharmaceutical Ind | JKU0880A | ND | ND | ND |
| 33 | 500 mg ER | Sun Pharmaceutical Ind | JKU2539A | ND | ND | ND |
| 34 | 500 mg ER | Tagi Pharma Inc | 5841,910035 | ND | ND | ND |
| 35 | 500 mg ER | Tagi Pharma Inc | 5841905129 | 0.015 d | 0.012 | ND |
| 36 | 500 mg ER | Time Cap Laboratories | XP9004 | 0.082 | 0.071 | 0.106 |
| 37 | 500 mg IR | Westminster Pharmaceuticals | B105067B | ND | ND | ND |
| 38 | 1000 mg IR | Westminster Pharmaceuticals | B107261B | ND | ND | ND |
IR indicates immediate release and ER indicates extended release
abcdAI for IR product is 0.038 ng/mg based on an maximum daily dose of 2550 mg; AI for ER product is 0.048 ng/mg based on an maximum daily dose of 2000 mg; ND = Not Detected (< LOD); value ≥ LOD but < LOQ; LOD and LOQ are 0.010 ng/mg and 0.030 ng/mg, respectively for FDA-1, and 0.005 ng/mg and 0.010 μg/g for FDA-2.