Cephalosporin Antibacterial
Where is Cefdinir made?
10 companies sell it under their own name and 22 repackagers rebottle it. Their labels name 4 factories in India and the United States.
India 3United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascend Laboratories, LLC125 mg per 5 mL, 250 mg per 5 mL, 300 mg · NDC 67877-547, 67877-548, 67877-543 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited125 mg per 5 mL, 250 mg per 5 mL, 300 mg · NDC 65862-218, 65862-219, 65862-177 | Aurobindo Pharma LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilySep 2023 |
| BluePoint Laboratories.300 mg · NDC 68001-362 | Aurobindo Pharma LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilySep 2023 |
| H.J. Harkins Co., Inc.125 mg per 5 mL, 250 mg per 5 mL · NDC 76519-1172, 76519-1214 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Lupin Pharmaceuticals, Inc.125 mg per 5 mL, 250 mg per 5 mL, 300 mg · NDC 68180-722, 68180-723, 68180-711 | Lupin LimitedMakes it and packages it | Mandideep, India | Serious problems, FDA actionNov 2022 |
| Major Pharmaceuticals300 mg · NDC 0904-7563 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Rising Pharma Holdings, Inc.300 mg · NDC 57237-099 | Aurobindo Pharma LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilySep 2023 |
| American Health Packaging300 mg · NDC 60687-699 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.300 mg · NDC 0781-2176 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.125 mg per 5 mL, 250 mg per 5 mL, 300 mg · NDC 0093-4136, 0093-4137, 0093-3160 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Cefdinir in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-6417,50090-4258,50090-7929,50090-3724+14 - Aidarex Pharmaceuticals LLC:
53217-298,33261-905,53217-406 - Asclemed USA, Inc.:
76420-327,76420-328,87063-345 - Atlantic Biologicals Corps.:
17856-1150 - AvKARE, Inc.:
42291-043 - Blenheim Pharmacal, Inc.:
10544-194 - Bryant Ranch Prepack:
63629-5101,63629-8968 - Coupler LLC:
67046-1298 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-044,70934-164 - Direct Rx:
72189-042,72189-185,72189-259,72189-043+4 - Dispensing Solutions Inc.:
68258-3053 - H.J. Harkins Co., Inc.:
52959-134 - Northwind Pharmaceuticals:
82868-059 - NuCare Pharmaceuticals.Inc.:
68071-2493,68071-2564,68071-4970,68071-3609+15 - PD-Rx Pharmaceuticals, Inc.:
43063-959,43063-964,72789-550,72789-061+1 - Physicians Total Care, Inc.:
54868-5768,54868-5769,54868-5767 - Preferred Pharmaceuticals, Inc..:
68788-8115,68788-8655,68788-7844,68788-4106+4 - Proficient Rx LP:
63187-835,63187-616,71205-380,71205-405+4 - RPK Pharmaceuticals, Inc.:
53002-2654,53002-1654,53002-1526,53002-2526 - Rebel Distributors Corp..:
21695-622,42254-127,21695-620,42254-177 - RedPharm Drug. Inc.:
67296-1232,67296-1291,67296-0765,67296-1448+4 - Remedyrepack Inc.:
70518-1880,70518-4169
Recalls
- May 8, 2024 · Class II · Lupin Pharmaceuticals Inc.
Defective container: lack of seal integrity. - Apr 24, 2024 · Class II · Lupin Pharmaceuticals Inc. · 2 recall notices
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. - Jul 2, 2020 · Class II · Lupin Pharmaceuticals Inc.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. - Nov 1, 2019 · Class III · Lupin Pharmaceuticals Inc. · 2 recall notices
Presence of Foreign substance: identified as a dead ant. - May 23, 2019 · Class II · Lupin Pharmaceuticals Inc.
Complaint received of metal piece identified in the product bottle prior to the reconstitution. - Jan 2, 2019 · Class II · Lupin Pharmaceuticals Inc. · 2 recall notices
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. - Mar 27, 2018 · Class II · Lupin Pharmaceuticals Inc.
Superpotent Drug - Feb 26, 2013 · Class II · Teva Pharmaceuticals USA, Inc.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.